Trial Outcomes & Findings for The PACE/PACENET Behavioral Health Laboratory Project (NCT NCT02440594)

Results Overview

A measure of overall mental health functioning as measured by the Medical Outcomes Survey Short Form (SF12) MCS subscale. Possible range = 0-100; higher scores mean better overall health functioning.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2432 participants

Primary outcome timeframe

Baseline and 3 and 6 month follow-up

Results posted on

2019-10-07

Participant Flow

To conduct the program evaluation, clinical record data were extracted for patients (newly prescribed an antidepressant (AD), anxiolytic (AX), or antipsychotic (AP)) and caregivers enrolled in the SUSTAIN (SUpporting Seniors Receiving Treatment And INtervention) program between 8/5/10 and 5/15/14 who completed a baseline clinical interview.

Participant milestones

Participant milestones
Measure	Enhanced Care High-Symptom AD/AX Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Caregiver TEP Intervention Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.	Caregiver Control Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services.
Overall Study STARTED	509	509	436	429	55	54	150	290
Overall Study COMPLETED	377	401	319	340	46	47	113	234
Overall Study NOT COMPLETED	132	108	117	89	9	7	37	56

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Care High-Symptom AD/AX Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Caregiver TEP Intervention Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.	Caregiver Control Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services.
Overall Study Lost to Follow-up	34	33	54	47	5	4	28	48
Overall Study Cognitive Impairment/Communication Issue	14	6	4	4	2	1	0	0
Overall Study Withdrawal by Subject	81	67	59	38	2	2	7	7
Overall Study Administratively w/drawn	3	2	0	0	0	0	2	1

Baseline Characteristics

The PACE/PACENET Behavioral Health Laboratory Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP n=436 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/ BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP n=429 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP n=55 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP n=54 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Caregiver TEP Intervention n=150 Participants Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Enhanced BHL Program Services which include: 1) a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services, and 2) the Telehealth Education Program (TEP) - BHPs provide manual and workbook-guided psychoeducation, support, and skills training.	Caregiver Control n=290 Participants Caregivers of patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who cannot participate due to cognitive impairment and meet criteria for dementia receive Standard BHL Program Services, which include a baseline clinical assessment of caregiver and care recipient factors (e.g., level of disability, burden, safety concerns) and contact information for local community services.	Total n=2432 Participants Total of all reporting groups
Age, Continuous	77.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	77.4 years STANDARD_DEVIATION 6.7 • n=7 Participants	78.1 years STANDARD_DEVIATION 6.6 • n=5 Participants	78.1 years STANDARD_DEVIATION 6.5 • n=4 Participants	76.6 years STANDARD_DEVIATION 6.7 • n=21 Participants	74.7 years STANDARD_DEVIATION 6.9 • n=8 Participants	63.3 years STANDARD_DEVIATION 11.9 • n=8 Participants	64.3 years STANDARD_DEVIATION 12.0 • n=24 Participants	77.6 years STANDARD_DEVIATION 6.8 • n=42 Participants
Sex: Female, Male Female	440 Participants n=5 Participants	407 Participants n=7 Participants	364 Participants n=5 Participants	352 Participants n=4 Participants	41 Participants n=21 Participants	43 Participants n=8 Participants	114 Participants n=8 Participants	208 Participants n=24 Participants	1969 Participants n=42 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	102 Participants n=7 Participants	72 Participants n=5 Participants	77 Participants n=4 Participants	14 Participants n=21 Participants	11 Participants n=8 Participants	36 Participants n=8 Participants	82 Participants n=24 Participants	463 Participants n=42 Participants
Race/Ethnicity, Customized Non-Hispanic White	472 Participants n=5 Participants	467 Participants n=7 Participants	405 Participants n=5 Participants	390 Participants n=4 Participants	54 Participants n=21 Participants	53 Participants n=8 Participants	132 Participants n=8 Participants	265 Participants n=24 Participants	2238 Participants n=42 Participants
Race/Ethnicity, Customized Other	37 Participants n=5 Participants	42 Participants n=7 Participants	31 Participants n=5 Participants	39 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	18 Participants n=8 Participants	25 Participants n=24 Participants	194 Participants n=42 Participants
Region of Enrollment United States	509 participants n=5 Participants	509 participants n=7 Participants	436 participants n=5 Participants	429 participants n=4 Participants	55 participants n=21 Participants	54 participants n=8 Participants	150 participants n=8 Participants	290 participants n=24 Participants	2432 participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline and 3 and 6 month follow-up

Population: SUSTAIN participants who were prescribed an AD or AX (per pharmacy records) and endorsed high baseline MH symptoms during the initial clinical interview. This was not a primary outcome measure for those patients assigned to the other 4 groups; data were extracted from clinical records only for patients assigned to the two designated arms.

A measure of overall mental health functioning as measured by the Medical Outcomes Survey Short Form (SF12) MCS subscale. Possible range = 0-100; higher scores mean better overall health functioning.

Outcome measures

Outcome measures
Measure	Enhanced Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score Baseline	47.52 score on a scale Standard Deviation 11.15	48.94 score on a scale Standard Deviation 10.14	—	—	—	—
Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score 3 month follow-up	51.03 score on a scale Standard Deviation 10.34	51.11 score on a scale Standard Deviation 9.97	—	—	—	—
Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score 6 month follow-up	51.92 score on a scale Standard Deviation 10.07	50.35 score on a scale Standard Deviation 10.58	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3 and 6 month follow-up

Population: Caregivers who completed a baseline clinical interview and agreed to SUSTAIN caregiver services.

Brief, 4-item version of the Zarit Burden Interview; Possible range = 0-16; higher scores denote greater perceived caregiving burden. This measure was only collected of caregivers who participated in SUSTAIN program services.

Outcome measures

Outcome measures
Measure	Enhanced Care High-Symptom AD/AX n=150 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX n=290 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
Zarit Burden Interview (ZBI) Baseline	6.54 score on a scale Standard Deviation 4.00	5.37 score on a scale Standard Deviation 4.34	—	—	—	—
Zarit Burden Interview (ZBI) 3 month follow-up	5.57 score on a scale Standard Deviation 4.03	5.36 score on a scale Standard Deviation 4.36	—	—	—	—
Zarit Burden Interview (ZBI) 6 month follow-up	5.37 score on a scale Standard Deviation 3.52	5.36 score on a scale Standard Deviation 4.22	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 3 and 6 month follow-up

Population: Analyses run for SUSTAIN program participants who were prescribed, 1) an AD or AX and endorsed high baseline MH symptoms during the initial clinical interview and, 2) an AP and endorsed high baseline MH symptoms. Due to their low baseline symptom severity, these outcome data were only collected/extracted at baseline for the low symptom groups.

A 9-item measure of depressive symptom severity in past 2 weeks. Possible range = 0-27; higher scores indicate higher depressive symptom severity.

Outcome measures

Outcome measures
Measure	Enhanced Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP n=55 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP n=54 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP n=436 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP n=429 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
Patient Health Questionnaire-9 (PHQ-9) Baseline	8.83 score on a scale Standard Deviation 4.56	8.64 score on a scale Standard Deviation 4.27	10.07 score on a scale Standard Deviation 5.14	10.33 score on a scale Standard Deviation 5.26	1.78 score on a scale Standard Deviation 1.44	1.79 score on a scale Standard Deviation 1.42
Patient Health Questionnaire-9 (PHQ-9) 3 month follow-up	5.70 score on a scale Standard Deviation 4.48	6.04 score on a scale Standard Deviation 4.72	7.45 score on a scale Standard Deviation 4.97	6.57 score on a scale Standard Deviation 6.28	—	—
Patient Health Questionnaire-9 (PHQ-9) 6 month follow-up	5.68 score on a scale Standard Deviation 4.57	6.82 score on a scale Standard Deviation 4.91	7.55 score on a scale Standard Deviation 4.12	8.38 score on a scale Standard Deviation 6.44	—	—

SECONDARY outcome

Timeframe: Baseline and 3 and 6 month follow-up

Population: SUSTAIN participants prescribed an antidepressant or anxiolytic and endorsed high baseline MH symptoms during the initial clinical interview. Due to their different symptom profiles and index medications, these outcome data were only collected/extracted at baseline for the low symptom and AP groups, respectively.

A 7-item measure of anxiety symptom severity over the past 2 weeks. Possible range = 0 - 21; higher scores indicated greater anxiety symptom severity

Outcome measures

Outcome measures
Measure	Enhanced Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AD/AX n=509 Participants Patients newly prescribed an antidepressant or anxiolytic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Care High-Symptom AP n=55 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Enhanced BHL Program Services, which include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Care Management Module - Care Management services with a BHP.	Standard Care High-Symptom AP n=54 Participants Patients newly prescribed an antipsychotic who report significant baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.	Enhanced Monitoring Low-Symptom AD/AX/AP n=436 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Enhanced BHL Program Services, which for this group include the: 1) Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues, and 2) Enhanced Monitoring via a one-time BHP follow-up call with the enrollee after 6 weeks to discuss continuing versus discontinuing the medication.	Standard Monitoring Low-Symptom AD/AX/AP n=429 Participants Patients newly prescribed an antidepressant, anxiolytic, or antipsychotic who report low baseline symptoms receive Standard BHL Program Services, which include the Standard Clinical Monitoring Module - evidence-based care consisting of up to 4 brief (5-10 minutes), structured assessments following the Core/baseline assessment. Interviews are conducted over the telephone by the Health Technician/BHP and take place during the initial 12 weeks of pharmaceutical treatment (e.g., 2, 6, 9, and 12 weeks), and monitor adherence, side effects, and treatment response. A progress report is provided to the prescribing clinician after each interview to help in treatment planning and to alert the clinician of special issues.
Generalized Anxiety Disorder - 7 (GAD-7) Baseline	4.75 units on a scale Standard Deviation 4.41	4.48 units on a scale Standard Deviation 4.21	5.85 units on a scale Standard Deviation 5.17	6.41 units on a scale Standard Deviation 5.29	0.88 units on a scale Standard Deviation 1.20	0.79 units on a scale Standard Deviation 1.07
Generalized Anxiety Disorder - 7 (GAD-7) 3 month follow-up	3.09 units on a scale Standard Deviation 3.72	3.42 units on a scale Standard Deviation 3.82	—	—	—	—
Generalized Anxiety Disorder - 7 (GAD-7) 6 month follow-up	2.79 units on a scale Standard Deviation 3.61	3.90 units on a scale Standard Deviation 4.34	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 3 and 6 month follow-up

Population: Numbers represent number of participants in each low symptom arm who met criteria for moderately severe - severe depression at 3 and 6 months. Due to their different symptom profiles, these outcome data were only collected/extracted at baseline for the high symptom groups.

Number of participants with moderately severe to severe depression at Baseline, 3 and 6 months; Depression diagnosis (i.e., moderately severe - severe depression vs. no - minimal depression or minor - moderate depression) based on a 9-item measure of depressive symptom severity in past 2 weeks.