Trial Outcomes & Findings for Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care (NCT NCT03151083)

Last Updated: 2023-07-21

Results Overview

The proportion of participants engaging in the program (completing at least one module) among the unique Veterans treated in VA Connecticut primary care over the respective intervention periods.

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

3 weeks following subject enrollment

Results posted on

2023-07-21

Participant Flow

Recruitment to digital CBTi occurred through primary care providers who made a referrals to the intervention. Referrals were addressed by the digital intervention coach (or research team member, depending on the cohort), who provided and initial education session about digital CBTi. Participants could then enroll in the trial if they wished. Over the entire course of the trial, 153 individuals were referred and 77 chose to enroll.

Participant milestones

Participant milestones
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team (June 2017 - January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (June 2018 to January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 3: Primary Care Mental Health Collaborative Care Implementation SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (April 2019 to November 2019). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated by the research team to provide education to patients about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow (Primary care provider placed consult in the medical record).
Overall Study STARTED	27	20	30
Overall Study COMPLETED	25	19	26
Overall Study NOT COMPLETED	2	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=27 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team (June 2017 - January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) n=20 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (June 2018 to January 2018). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 3: Primary Care Mental Health Collaborative Care Implementation n=30 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams (April 2019 to November 2019). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated by the research team to provide education to patients about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow (Primary care provider placed consult in the medical record).	Total n=77 Participants Total of all reporting groups
Age, Customized <=55	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Age, Customized >55,<=65	9 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Age, Customized >65	10 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	66 Participants n=4 Participants
Race/Ethnicity, Customized White/non-Hispanic	21 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants	58 Participants n=4 Participants
Race/Ethnicity, Customized African American/Non-Hispanic	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Any Mental Health Diagnosis Any Mental Health Diagnosis	12 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants	35 Participants n=4 Participants
Any Mental Health Diagnosis No Mental Health Diagnosis	15 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	42 Participants n=4 Participants
Number of Medical Diagnoses <5	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Number of Medical Diagnoses >=5, <10	10 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Number of Medical Diagnoses >=10	13 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants	39 Participants n=4 Participants
Any Sedative-Hypnotic Prescription Any Sedative-Hypnotic Prescription	6 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants
Any Sedative-Hypnotic Prescription No Sedative-Hypnotic Prescription	21 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	55 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 weeks following subject enrollment

Population: Unique Veterans treated in VA Connecticut primary care over the respective intervention periods.

The proportion of participants engaging in the program (completing at least one module) among the unique Veterans treated in VA Connecticut primary care over the respective intervention periods.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=12658 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) n=13592 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation n=13572 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Program Engagement: Completion of the First Program Module	17 Participants	12 Participants	16 Participants

SECONDARY outcome

Timeframe: 10 Weeks following subject enrollment

Population: Individuals enrolled in the trial over the respective active implementation period.

Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=27 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) n=20 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation n=30 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Program Completion	10 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Over each 8-month active implementation Phase

Population: Denominator of providers with the potential to make referrals over each period is estimated due to frequent provider transitions, changes to the referral process, and training programs within primary care.

The number of providers who made a referral to the SHUTi Program among the number of providers with the ability to make a referral.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=60 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) n=60 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation n=60 Participants SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Provider Adoption	31 Participants	26 Participants	34 Participants

SECONDARY outcome

Timeframe: At enrollment and 10 weeks following enrollment.

Population: All enrollees in the trial.

The ISI will be the primary clinical outcome and is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia. The outcome reported is the change in total ISI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The Insomnia Severity Index to total is the sum on 7 questions scored 0 to 4 (minimum=0, Maximum=28). Higher scores indicate more severe insomnia.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=70 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Insomnia Severity Index	4.3 score on a scale Standard Deviation 5.6	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment and 10 weeks following enrollment

The BDI is a secondary clinical outcome and is a self-report measure of depression severity. The outcome reported is the change in total BDI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The BDI is a 21-item, self-report rating inventory of depression symptoms. Items receive a rating of zero to three and are summed linearly to create a score which ranges from 0 to 63. Higher score indicate more intense symptoms of depression.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=70 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Beck Depression Inventory	3.1 score on a scale Standard Deviation 5.5	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment and 10 weeks following enrollment

The use of sedative-hypnotics will be measured by self-report of the type and dose of specific medications used in the last week. The outcome reported is the change in the reported total weekly number of sedative-hypnotic doses reported from baseline compared to follow-up.

Outcome measures

Outcome measures
Measure	Phase 1: Implementation As Usual (Implementation Through Research Team) n=70 Participants SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).	Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.	Phase 3: Primary Care Mental Health Collaborative Care Implementation SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Sedative-Hypnotic Medication Use	2.2 weekly sedative-hypnotic doses Standard Deviation 6.6	—	—

Adverse Events

All Enrollees

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Hermes

VA Connecticut Healthcare System

Phone: 203 932 5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place