Trial Outcomes & Findings for Scaling Up Science-based Mental Health Interventions in Latin America (NCT NCT03392883)

Last Updated: 2022-11-09

Results Overview

This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).

Recruitment status

COMPLETED

Study phase

Target enrollment

1348 participants

Primary outcome timeframe

At 6- and 12-month follow-up visits with a sub-sample of participants

Results posted on

2022-11-09

Participant Flow

At the primary care site patients upon arrival were asked to complete screeners (for depression and problematic alcohol use). In the event of positive screen for depression and/or alcohol use problems, clinicians at site completed an in-depth diagnostic interview. Participants who met all inclusionary criteria were informed about this project and provided an informed consent form. Providers and administrators who worked for the site for at least 3 months were asked to participate.

Participant milestones

Participant milestones
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.	Providers in Digital Health Assisted Mental Healthcare Intervention Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.	Administrative Staff in Digital Health Assisted Mental Healthcare Intervention Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
Overall Study STARTED	1264	45	39
Overall Study COMPLETED	928	32	30
Overall Study NOT COMPLETED	336	13	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.	Providers in Digital Health Assisted Mental Healthcare Intervention Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.	Administrative Staff in Digital Health Assisted Mental Healthcare Intervention Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
Overall Study Lost to Follow-up	122	13	9
Overall Study Death	4	0	0
Overall Study Lack of Efficacy	29	0	0
Overall Study Withdrawal by Subject	180	0	0
Overall Study Adverse Event	1	0	0

Baseline Characteristics

This measure is not administered to providers and administrative staff.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1264 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.	Providers in Digital Health Assisted Mental Healthcare Intervention n=45 Participants Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.	Administrative Staff in Digital Health Assisted Mental Healthcare Intervention n=39 Participants Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.	Total n=1348 Participants Total of all reporting groups
Age, Continuous	49.60 years STANDARD_DEVIATION 17.28 • n=1264 Participants	32.87 years STANDARD_DEVIATION 10.12 • n=45 Participants	36.39 years STANDARD_DEVIATION 12.51 • n=39 Participants	48.88 years STANDARD_DEVIATION 17.34 • n=1348 Participants
Sex: Female, Male Female	969 Participants n=1264 Participants	30 Participants n=45 Participants	27 Participants n=39 Participants	1026 Participants n=1348 Participants
Sex: Female, Male Male	295 Participants n=1264 Participants	15 Participants n=45 Participants	12 Participants n=39 Participants	322 Participants n=1348 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	991 Participants n=1264 Participants	42 Participants n=45 Participants	34 Participants n=39 Participants	1067 Participants n=1348 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=1264 Participants	0 Participants n=45 Participants	1 Participants n=39 Participants	21 Participants n=1348 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	253 Participants n=1264 Participants	3 Participants n=45 Participants	4 Participants n=39 Participants	260 Participants n=1348 Participants
Race (NIH/OMB) American Indian or Alaska Native	23 Participants n=1264 Participants	0 Participants n=45 Participants	1 Participants n=39 Participants	24 Participants n=1348 Participants
Race (NIH/OMB) Asian	0 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=1348 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=1348 Participants
Race (NIH/OMB) Black or African American	10 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	10 Participants n=1348 Participants
Race (NIH/OMB) White	232 Participants n=1264 Participants	9 Participants n=45 Participants	7 Participants n=39 Participants	248 Participants n=1348 Participants
Race (NIH/OMB) More than one race	681 Participants n=1264 Participants	22 Participants n=45 Participants	23 Participants n=39 Participants	726 Participants n=1348 Participants
Race (NIH/OMB) Unknown or Not Reported	318 Participants n=1264 Participants	14 Participants n=45 Participants	8 Participants n=39 Participants	340 Participants n=1348 Participants
Region of Enrollment Colombia	1264 participants n=1264 Participants	45 participants n=45 Participants	39 participants n=39 Participants	1348 participants n=1348 Participants
Name of Primary Care Center Site Javesalud - Bogota	483 Participants n=1264 Participants	13 Participants n=45 Participants	12 Participants n=39 Participants	508 Participants n=1348 Participants
Name of Primary Care Center Site Hospital Regional de Duitama	471 Participants n=1264 Participants	14 Participants n=45 Participants	6 Participants n=39 Participants	491 Participants n=1348 Participants
Name of Primary Care Center Site Hospital Santa Rosa de Viterbo	196 Participants n=1264 Participants	8 Participants n=45 Participants	6 Participants n=39 Participants	210 Participants n=1348 Participants
Name of Primary Care Center Site Hospital Granja de Lerida	27 Participants n=1264 Participants	5 Participants n=45 Participants	9 Participants n=39 Participants	41 Participants n=1348 Participants
Name of Primary Care Center Site Hospital de Chaparral	78 Participants n=1264 Participants	3 Participants n=45 Participants	3 Participants n=39 Participants	84 Participants n=1348 Participants
Name of Primary Care Center Site Hospital Armero Guayabal	9 Participants n=1264 Participants	2 Participants n=45 Participants	3 Participants n=39 Participants	14 Participants n=1348 Participants
Name of Primary Care Center Site Prefer not to respond	0 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=1348 Participants
Education Level None	34 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	34 Participants n=1348 Participants
Education Level Preschool	1 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	1 Participants n=1348 Participants
Education Level Kindergarten	0 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=1348 Participants
Education Level Grade 1	64 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	64 Participants n=1348 Participants
Education Level Grade 2	71 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	71 Participants n=1348 Participants
Education Level Grade 3	72 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	72 Participants n=1348 Participants
Education Level Grade 4	47 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	47 Participants n=1348 Participants
Education Level Grade 5	178 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	178 Participants n=1348 Participants
Education Level Grade 6	36 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	36 Participants n=1348 Participants
Education Level Grade 7	43 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	43 Participants n=1348 Participants
Education Level Grade 8	31 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	31 Participants n=1348 Participants
Education Level Grade 9	40 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	40 Participants n=1348 Participants
Education Level Grade 10	17 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	17 Participants n=1348 Participants
Education Level Grade 11	21 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	21 Participants n=1348 Participants
Education Level Secondary Education Diploma	198 Participants n=1264 Participants	0 Participants n=45 Participants	1 Participants n=39 Participants	199 Participants n=1348 Participants
Education Level Technical Studies	149 Participants n=1264 Participants	2 Participants n=45 Participants	9 Participants n=39 Participants	160 Participants n=1348 Participants
Education Level Less than one year of university	18 Participants n=1264 Participants	0 Participants n=45 Participants	1 Participants n=39 Participants	19 Participants n=1348 Participants
Education Level Diploma	4 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	4 Participants n=1348 Participants
Education Level University Degree	8 Participants n=1264 Participants	2 Participants n=45 Participants	1 Participants n=39 Participants	11 Participants n=1348 Participants
Education Level Master's Degree	18 Participants n=1264 Participants	13 Participants n=45 Participants	12 Participants n=39 Participants	43 Participants n=1348 Participants
Education Level Professional Degree	135 Participants n=1264 Participants	28 Participants n=45 Participants	14 Participants n=39 Participants	177 Participants n=1348 Participants
Education Level Doctorate	1 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	1 Participants n=1348 Participants
Education Level At least one year in two-year university program	21 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	21 Participants n=1348 Participants
Education Level One year in four-year university program	13 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	13 Participants n=1348 Participants
Education Level Two years in four-year university program	9 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	9 Participants n=1348 Participants
Education Level At least three years in four-year university program	35 Participants n=1264 Participants	0 Participants n=45 Participants	1 Participants n=39 Participants	36 Participants n=1348 Participants
Education Level Unknown or prefers not to respond	0 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=1348 Participants
Socioeconomic Status Rural Area	168 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	168 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 1	300 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	300 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 2	316 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	316 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 3	272 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	272 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 4	152 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	152 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 5	33 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	33 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Stratum 6	9 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	9 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Socioeconomic Status Prefers not to respond	14 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	14 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Full-time Employed	171 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	171 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Self-employed	286 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	286 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Part-time Employed	49 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	49 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Unemployed, seeking jobs	112 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	112 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Unemployed, not seeking jobs	39 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	39 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Unable to work	25 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	25 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Pensioner	75 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	75 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Housekeeper	428 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	428 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Student	70 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	70 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Employment Status Prefers not to respond	9 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	9 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Single	399 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	399 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Married or Free Union	544 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	544 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Separated	172 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	172 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Divorced	36 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	36 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Widowed	107 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	107 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Marital Status Prefers not to respond	6 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	6 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Number of persons in household 0	130 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	130 Participants n=1348 Participants
Number of persons in household 1	312 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	312 Participants n=1348 Participants
Number of persons in household 2	277 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	277 Participants n=1348 Participants
Number of persons in household 3	253 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	253 Participants n=1348 Participants
Number of persons in household 4	148 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	148 Participants n=1348 Participants
Number of persons in household 5	77 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	77 Participants n=1348 Participants
Number of persons in household 6	33 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	33 Participants n=1348 Participants
Number of persons in household 7	16 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	16 Participants n=1348 Participants
Number of persons in household 8	8 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	8 Participants n=1348 Participants
Number of persons in household 9	4 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	4 Participants n=1348 Participants
Number of persons in household 10	1 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	1 Participants n=1348 Participants
Number of persons in household 11	2 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	2 Participants n=1348 Participants
Number of persons in household 12	1 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	1 Participants n=1348 Participants
Number of persons in household 14	2 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	2 Participants n=1348 Participants
Health Insurance Status No insurance	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Subsidized plan (ARS, SISBEN, EPS-S)	845 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	845 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Contributory plan (EPS)	413 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	413 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Indigenous Health plan	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Supplemental plan or prepaid medical plan	4 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	4 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Special plan (Armed Forces, Ecopetrol)	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Health Insurance Status Prefers not to respond	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Length of time to reach healthcare center 0-29 minutes	631 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	631 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Length of time to reach healthcare center 30-59 minutes	464 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	464 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Length of time to reach healthcare center 60-120 minutes	134 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	134 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Length of time to reach healthcare center More than 120 minutes	34 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	34 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Length of time to reach healthcare center Prefers not to respond	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of previous depressive episodes 0 episodes	890 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	890 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of previous depressive episodes 1 episode	225 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	225 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of previous depressive episodes 2 episodes	70 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	70 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of previous depressive episodes 3 episodes	71 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	71 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of previous depressive episodes Prefers not to respond	8 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	8 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events No traumatic events	500 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	500 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 1	372 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	372 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 2	199 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	199 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 3	83 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	83 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 4	37 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	37 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 5	24 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	24 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 6	10 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	10 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 7	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 9	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events 10	6 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	6 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
History of Traumatic Events Prefers not to respond	31 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	31 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Family History of Depression Parents with depression	163 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	163 Participants n=1348 Participants
Family History of Depression Siblings with depression	133 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	133 Participants n=1348 Participants
Family History of Depression First degree relatives with depression	132 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	132 Participants n=1348 Participants
Family History of Depression No family history of depression	764 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	764 Participants n=1348 Participants
Family History of Depression Prefers not to respond	156 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	156 Participants n=1348 Participants
Family History of Harmful Alcohol Use Parents with harmful alcohol use	473 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	473 Participants n=1348 Participants
Family History of Harmful Alcohol Use Siblings with harmful alcohol use	356 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	356 Participants n=1348 Participants
Family History of Harmful Alcohol Use First degree relatives with harmful alcohol use	367 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	367 Participants n=1348 Participants
Family History of Harmful Alcohol Use No family history of harmful alcohol use	605 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	605 Participants n=1348 Participants
Family History of Harmful Alcohol Use Prefers not to respond	18 Participants n=1264 Participants	0 Participants n=45 Participants	0 Participants n=39 Participants	18 Participants n=1348 Participants
Smartphone Use Yes - has a smartphone.	882 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	882 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Smartphone Use No - does not have a smartphone	382 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	382 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Internet Use Yes, uses the Internet	843 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	843 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Internet Use No, does not use the Internet	421 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	421 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Tobacco Use Current smoker	163 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	163 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Tobacco Use Former smoker	414 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	414 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Tobacco Use Never smoked	686 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	686 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Tobacco Use Prefers not to respond	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Antidepressants Use Yes	187 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	187 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Antidepressants Use No	1075 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1075 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Antidepressants Use Prefers not to respond	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Psychotherapy Treatment Use Yes	213 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	213 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Psychotherapy Treatment Use No	1048 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1048 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Psychotherapy Treatment Use Prefers not to respond	3 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	3 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Alcoholics Anonymous Yes	12 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	12 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Alcoholics Anonymous No	1252 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1252 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Alcoholics Anonymous Prefers not to respond	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Medication for controlling problematic alcohol use Yes	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Medication for controlling problematic alcohol use No	1262 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1262 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Medication for controlling problematic alcohol use Prefers not to respond	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Tobacco	163 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	163 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Cannabis	53 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	53 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Cocaine	7 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	7 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Prescription Stimulants	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	2 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Methamphetamine	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Sedatives	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Hallucinogens	5 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	5 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Street Opioids	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.
Substance Use Prescription Opioids	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	0 Participants This measure is not administered to providers and administrative staff.	1 Participants n=1264 Participants • This measure is not administered to providers and administrative staff.

PRIMARY outcome

Timeframe: At 6- and 12-month follow-up visits with a sub-sample of participants

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=166 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 6-month follow-up Adoption	2.76 score on a scale Standard Deviation 0.58
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 6-month follow-up Acceptability	3.22 score on a scale Standard Deviation 0.64
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 6-month follow-up Appropriateness	3.21 score on a scale Standard Deviation 0.64
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 6-month follow-up Feasibility	2.91 score on a scale Standard Deviation 0.62
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 6-month follow-up Reach/Access	2.59 score on a scale Standard Deviation 0.69
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 12-month follow-up Adoption	3.05 score on a scale Standard Deviation 0.62
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 12-month follow-up Acceptability	3.27 score on a scale Standard Deviation 0.61
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 12-month follow-up Appropriateness	3.28 score on a scale Standard Deviation 0.50
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 12-month follow-up Feasibility	2.93 score on a scale Standard Deviation 0.54
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument 12-month follow-up Reach/Access	2.67 score on a scale Standard Deviation 0.66

PRIMARY outcome

Timeframe: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups.

This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=24 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Adoption at Baseline	2.95 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Adoption at 6 months	2.65 score on a scale Standard Deviation 0.61
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Adoption at 12 months	2.93 score on a scale Standard Deviation 0.43
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Adoption at 18 months	2.92 score on a scale Standard Deviation 0.51
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Adoption at 24 months	2.85 score on a scale Standard Deviation 0.68
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Accessibility at Baseline	3.41 score on a scale Standard Deviation 0.51
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Accessibility at 6 months	3.35 score on a scale Standard Deviation 0.45
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Accessibility at 12 months	3.50 score on a scale Standard Deviation 0.47
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Accessibility at 18 months	3.55 score on a scale Standard Deviation 0.32
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Accessibility at 24 months	3.38 score on a scale Standard Deviation 0.44
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Appropriateness at Baseline	3.40 score on a scale Standard Deviation 0.34
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Appropriateness at 6 months	3.32 score on a scale Standard Deviation 0.47
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Appropriateness at 12 months	3.52 score on a scale Standard Deviation 0.31
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Appropriateness at 18 months	3.41 score on a scale Standard Deviation 0.42
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Appropriateness at 24 months	3.16 score on a scale Standard Deviation 0.48
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Feasibility at Baseline	2.94 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Feasibility at 6 months	2.88 score on a scale Standard Deviation 0.38
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Feasibility at 12 months	2.72 score on a scale Standard Deviation 0.40
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Feasibility at 18 months	3.01 score on a scale Standard Deviation 0.31
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Feasibility at 24 months	2.84 score on a scale Standard Deviation 0.63
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Resources at Baseline	3.14 score on a scale Standard Deviation 0.65
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Resources at 6 months	3.08 score on a scale Standard Deviation 0.42
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Resources at 12 months	2.98 score on a scale Standard Deviation 0.47
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Resources at 18 months	3.17 score on a scale Standard Deviation 0.44
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Resources at 24 months	3.14 score on a scale Standard Deviation 0.64
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Reach/Access at Baseline	2.78 score on a scale Standard Deviation 0.65
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Reach/Access at 6 months	2.85 score on a scale Standard Deviation 0.48
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Reach/Access at 12 months	2.96 score on a scale Standard Deviation 0.44
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Reach/Access at 18 months	3.00 score on a scale Standard Deviation 0.52
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Reach/Access at 24 months	2.91 score on a scale Standard Deviation 0.22
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Organizational Climate at Baseline	3.42 score on a scale Standard Deviation 0.44
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Organizational Climate at 6 months	3.43 score on a scale Standard Deviation 0.43
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Organizational Climate at 12 months	3.56 score on a scale Standard Deviation 0.30
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Organizational Climate at 18 months	3.60 score on a scale Standard Deviation 0.35
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Organizational Climate at 24 months	3.43 score on a scale Standard Deviation 0.61
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Leadership in Implementing at Baseline	3.38 score on a scale Standard Deviation 0.65
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Leadership in Implementing at 6 months	3.24 score on a scale Standard Deviation 0.64
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Leadership in Implementing at 12 months	3.46 score on a scale Standard Deviation 0.41
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Leadership in Implementing at 18 months	3.57 score on a scale Standard Deviation 0.44
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument Leadership in Implementing at 24 months	3.06 score on a scale Standard Deviation 0.86
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument General Leadership Skills at Baseline	3.32 score on a scale Standard Deviation 0.67
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument General Leadership Skills at 6 months	3.36 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument General Leadership Skills at 12 months	3.48 score on a scale Standard Deviation 0.45
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument General Leadership Skills at 18 months	3.48 score on a scale Standard Deviation 0.50
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument General Leadership Skills at 24 months	3.20 score on a scale Standard Deviation 0.94

PRIMARY outcome

Timeframe: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.

This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=27 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Knowledge at Baseline	1.95 score on a scale Standard Deviation 0.48
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Adoption at Baseline	3.38 score on a scale Standard Deviation 0.47
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Adoption at 6 months	3.37 score on a scale Standard Deviation 0.46
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Adoption at 12 months	3.69 score on a scale Standard Deviation 0.40
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Adoption at 18 months	3.87 score on a scale Standard Deviation 0.22
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Adoption at 24 months	3.50 score on a scale Standard Deviation 0.67
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Accessibility at Baseline	3.77 score on a scale Standard Deviation 0.37
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Accessibility at 6 months	3.50 score on a scale Standard Deviation 0.39
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Accessibility at 12 months	3.50 score on a scale Standard Deviation 0.42
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Accessibility at 18 months	3.60 score on a scale Standard Deviation 0.42
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Accessibility at 24 months	3.39 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Appropriateness at Baseline	3.54 score on a scale Standard Deviation 0.37
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Appropriateness at 6 months	2.77 score on a scale Standard Deviation 0.89
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Appropriateness at 12 months	2.99 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Appropriateness at 18 months	3.19 score on a scale Standard Deviation 0.53
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Appropriateness at 24 months	3.07 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Feasibility at Baseline	2.88 score on a scale Standard Deviation 0.60
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Feasibility at 6 months	3.17 score on a scale Standard Deviation 0.52
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Feasibility at 12 months	2.96 score on a scale Standard Deviation 0.55
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Feasibility at 18 months	3.20 score on a scale Standard Deviation 0.49
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Feasibility at 24 months	3.17 score on a scale Standard Deviation 0.59
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Reach/Access at Baseline	2.93 score on a scale Standard Deviation 0.58
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Reach/Access at 6 months	3.41 score on a scale Standard Deviation 0.62
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Reach/Access at 12 months	3.47 score on a scale Standard Deviation 0.54
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Reach/Access at 18 months	3.70 score on a scale Standard Deviation 0.35
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Reach/Access at 24 months	3.58 score on a scale Standard Deviation 0.27
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Organizational Climate at Baseline	3.39 score on a scale Standard Deviation 0.43
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Organizational Climate at 6 months	3.20 score on a scale Standard Deviation 0.77
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Organizational Climate at 12 months	3.22 score on a scale Standard Deviation 0.63
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Organizational Climate at 18 months	3.52 score on a scale Standard Deviation 0.64
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Organizational Climate at 24 months	3.47 score on a scale Standard Deviation 0.48
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Leadership in Implementing at Baseline	3.29 score on a scale Standard Deviation 0.69
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Leadership in Implementing at 6 months	3.17 score on a scale Standard Deviation 0.78
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Leadership in Implementing at 12 months	3.25 score on a scale Standard Deviation 0.80
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Leadership in Implementing at 18 months	3.65 score on a scale Standard Deviation 0.37
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Leadership in Implementing at 24 months	3.47 score on a scale Standard Deviation 0.45
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument General Leadership Skills at Baseline	3.34 score on a scale Standard Deviation 0.56
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument General Leadership Skills at 6 months	2.42 score on a scale Standard Deviation 1.02
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument General Leadership Skills at 12 months	2.92 score on a scale Standard Deviation 0.81
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument General Leadership Skills at 18 months	2.44 score on a scale Standard Deviation 0.63
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument General Leadership Skills at 24 months	2.80 score on a scale Standard Deviation 1.05
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Knowledge at 6 months	1.95 score on a scale Standard Deviation 0.28
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Knowledge at 12 months	1.92 score on a scale Standard Deviation 0.27
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Knowledge at 18 months	1.91 score on a scale Standard Deviation 0.26
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument Knowledge at 24 months	1.92 score on a scale Standard Deviation 0.26

PRIMARY outcome

Timeframe: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data is collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.

This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=41 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Program Sustainability Assessment Tool (PSAT) Providers Baseline overall	3.01 score on a scale Standard Deviation 0.61
The Program Sustainability Assessment Tool (PSAT) Providers 6 months follow-up overall	2.91 score on a scale Standard Deviation 0.63
The Program Sustainability Assessment Tool (PSAT) Providers 12 months follow-up overall	2.99 score on a scale Standard Deviation 0.41
The Program Sustainability Assessment Tool (PSAT) Providers 18 months follow-up overall	3.01 score on a scale Standard Deviation 0.51
The Program Sustainability Assessment Tool (PSAT) Providers 24 months follow-up overall	2.82 score on a scale Standard Deviation 0.63

PRIMARY outcome

Timeframe: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data was collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.

This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=30 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Program Sustainability Assessment Tool (PSAT) Administrative Staff Baseline overall	2.72 score on a scale Standard Deviation 0.58
The Program Sustainability Assessment Tool (PSAT) Administrative Staff 6 months follow-up overall	3.14 score on a scale Standard Deviation 0.37
The Program Sustainability Assessment Tool (PSAT) Administrative Staff 12 months follow-up overall	3.23 score on a scale Standard Deviation 0.27
The Program Sustainability Assessment Tool (PSAT) Administrative Staff 18 months follow-up overall	3.41 score on a scale Standard Deviation 0.29
The Program Sustainability Assessment Tool (PSAT) Administrative Staff 24 months follow-up overall	3.32 score on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient).

Population: Only patient participants with a depression diagnosis completed the PHQ assessment at all timepoints. The number of participants analyzed varies at each assessment timepoint due to participants unable to reach during the window of follow-up and participants who withdrew from the study.

A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms.

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1214 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
Patient Health Questionnaire (PHQ-8) 12-Month	4.67 score on a scale Standard Deviation 4.38
Patient Health Questionnaire (PHQ-8) Baseline	11.32 score on a scale Standard Deviation 5.07
Patient Health Questionnaire (PHQ-8) 3-Month	5.82 score on a scale Standard Deviation 5.09
Patient Health Questionnaire (PHQ-8) 6-Month	5.51 score on a scale Standard Deviation 4.94
Patient Health Questionnaire (PHQ-8) 9-Month	5.37 score on a scale Standard Deviation 4.67

SECONDARY outcome

Timeframe: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient).

Population: The number of participants analyzed differs at each assessment timepoint due to a number of participants who were unable to reach during the designated window of assessment and participants who actively withdrew from the study for various non-safety related reasons.

The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days.

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1264 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Baseline Total Sum Score	23.07 score on a scale Standard Deviation 7.72
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 3-Month Total Sum Score	19.55 score on a scale Standard Deviation 7.30
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 6-Month Total Sum Score	19.32 score on a scale Standard Deviation 7.50
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 9-Month Total Sum Score	18.87 score on a scale Standard Deviation 6.98
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 12-Month Total Sum Score	18.59 score on a scale Standard Deviation 6.73

SECONDARY outcome

Timeframe: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).

Population: Number of participants analyzed differ at each assessment timepoint because some participants were unable to be reached during the designated window of follow-up and some participants withdrew from the study.

The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety.

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1264 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
General Anxiety Disorder Screener (GAD-7) Baseline	9.11 score on a scale Standard Deviation 5.43
General Anxiety Disorder Screener (GAD-7) 3-Month	5.21 score on a scale Standard Deviation 4.65
General Anxiety Disorder Screener (GAD-7) 6-Month	4.63 score on a scale Standard Deviation 4.35
General Anxiety Disorder Screener (GAD-7) 9-Month	4.05 score on a scale Standard Deviation 3.97
General Anxiety Disorder Screener (GAD-7) 12-Month	3.34 score on a scale Standard Deviation 3.69

SECONDARY outcome

Timeframe: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants).

Population: The overall number of participants is different from the overall number of the patients arm, because this assessment was only administered to patients diagnosed with alcohol use disorder. There are different numbers of participants analyzed at each timepoint due to a number of participants who were unable to be reached in the designated window of follow-up and who withdrew from the study.

The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints).

Outcome measures

Outcome measures
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=168 Participants Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management.
The Quick Drinking Screen (QDS) (for Full Implementation Study Only) Baseline Standard Drinks per Week	22.74 standard drinks per week Standard Deviation 28.28
The Quick Drinking Screen (QDS) (for Full Implementation Study Only) 3-Month Standard Drinks per Week	35.20 standard drinks per week Standard Deviation 96.14
The Quick Drinking Screen (QDS) (for Full Implementation Study Only) 6-Month Standard Drinks per Week	46.37 standard drinks per week Standard Deviation 102.00
The Quick Drinking Screen (QDS) (for Full Implementation Study Only) 9-Month Standard Drinks per Week	38.11 standard drinks per week Standard Deviation 80.02
The Quick Drinking Screen (QDS) (for Full Implementation Study Only) 12-Month Standard Drinks per Week	25.33 standard drinks per week Standard Deviation 72.61

Serious adverse events
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1264 participants at risk Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management.
Endocrine disorders Thyroidectomy	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Removal of Gallbladder	0.32% 4/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Catheterization	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Liver Complications	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Suicidality	2.2% 28/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Paralysis due to Parkinson's Disease	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Hospitalization due to Diarrhea	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Chest Pain	0.40% 5/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Blood and lymphatic system disorders Hospitalization due to Hyperglycemia	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Spinal Surgery	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Heart Dysfunction	0.63% 8/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Renal and urinary disorders Renal Procedure	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Injury, poisoning and procedural complications Broken Limb	0.32% 4/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Colon Procedure	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Related Surgery and Treatment	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Infections and infestations Shingles	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Manic Episode	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Total Knee Replacement	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Caesarean Section Procedure	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Epilepsy	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Infections and infestations Urinary Tract Infection	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Infections and infestations Infection in Leg	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Facial Paralysis	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Curettage Biopsy	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Hernia Repair	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.47% 6/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Worsening Depression without Suicidality	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Surgery for Hand Trauma	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Blood and lymphatic system disorders Blood Transfusion for Anemia	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
General disorders Cysts	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Hip Replacement	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Endoscopic retrograde cholangiopancreatography	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Infections and infestations Hospitalization due to COVID-19 Infection	1.7% 21/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Herniated Disc	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Arthroscopy Procedure	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Appendectomy	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
General disorders Gastritis	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Surgical and medical procedures Abdominal Pain	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.

Other adverse events

Other adverse events
Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n=1264 participants at risk Patients will be offered a multi-component model of science-based mental health care. All participants who consent to participate will be given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site will show them how to use the tool. Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program will secondarily focus on problematic alcohol use and its relationship to depression management.
Psychiatric disorders Medical appointment due to non-serious diagnosis related symptoms	31.9% 403/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Infections and infestations COVID-19 Infection	6.6% 84/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
General disorders Headaches	0.32% 4/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Vertigo Episode	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Resection of Malignant Mass on Face	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Displacement and imbalance	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Nervous system disorders Facial Paralysis	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
General disorders Fever and face rash	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Blood and lymphatic system disorders Complication of chronic venous insufficiency	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Worsening of Depressive Symptoms	1.8% 23/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Panic attack	0.79% 10/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Suicide ideation with risk of self-harm	0.55% 7/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Worsening of depression symptoms secondary to autoimmune disease complication	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Psychiatric disorders Parasuicide behavior	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.87% 11/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Excision of Uterine Fibroid	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Tubal ligation surgery	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Ovary and thyroid cysts	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Excision of ovarian myoma	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Post-abortion difficulties	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Pregnancy, puerperium and perinatal conditions Pregnancy miscarriage	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Pregnancy, puerperium and perinatal conditions Bleeding related to pregnancy	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Vaginal bleeding	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Reproductive system and breast disorders Resection of endometrial polyps	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Injury, poisoning and procedural complications Trauma related to fall injuries	0.55% 7/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Injury, poisoning and procedural complications Work accident	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Injury, poisoning and procedural complications Accident under alcohol influence	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Eye disorders Eye Procedure	0.40% 5/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Eye disorders Ocular hemorrhage	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Abdominal pain	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Food poisoning	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Gastritis	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Resection of Gastric and Duodenal Polyps	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Stomach virus	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Liquid stools	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Gastrointestinal disorders Gastric ulcer	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Respiratory, thoracic and mediastinal disorders Respiratory problems	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Respiratory, thoracic and mediastinal disorders Acute bronchitis	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Chest pain	0.24% 3/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Pacemaker procedure	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Arrythmia Tachycardia	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Hypertension	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Varicose Vein Surgery	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Cardiac disorders Heart murmur	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Injury, poisoning and procedural complications Ankle trauma	0.16% 2/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Mild Carpal Tunnel	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Hyperextension in Spine	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Broken Finger	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Spinal surgery	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Broken arm	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Knee pain	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Muscle Pain	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Musculoskeletal and connective tissue disorders Vocal cords surgery	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Renal and urinary disorders Diabetes diagnosis	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Renal and urinary disorders Kidney stone	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Renal and urinary disorders Urinary tract infection	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Endocrine disorders Tiroidectomy	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.
Endocrine disorders Biopsy of thyroid nodules	0.08% 1/1264 • 12 months after baseline assessment. The study collected and reported adverse events only for patient participants. Adverse event collection was not conducted for providers and administrators.

Additional Information

Lisa A. Marsch, PhD

Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College

Phone: 603-646-7092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place