Trial Outcomes & Findings for eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients (NCT NCT02458690)

Last Updated: 2023-10-19

Results Overview

Brachial FMD was measured per consensus guidelines using a GE LOGIQe high-resolution ultrasound with a 15-MHz vascular transducer. After a 10-minute supine rest period, a BP cuff was placed on the forearm and inflated to 250 mmHg for five minutes. Brachial diameter was measured at pre-inflation and 60- and 90-seconds post-deflation using AccessPoint 2011 software (version 8.2). FMD was computed the maximum % increase in brachial diameter at 60- or 90-seconds post-deflation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

216 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	eIMPACT eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Overall Study STARTED	107	109
Overall Study COMPLETED	99	100
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.	Total n=216 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 6.0 • n=5 Participants	58.9 years STANDARD_DEVIATION 5.4 • n=7 Participants	58.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	86 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=5 Participants	104 Participants n=7 Participants	206 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	52 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants	109 participants n=7 Participants	216 participants n=5 Participants
Brachial Artery Flow-Mediated Dilation	2.59 % increase in brachial diameter STANDARD_DEVIATION 2.16 • n=5 Participants	2.85 % increase in brachial diameter STANDARD_DEVIATION 2.45 • n=7 Participants	2.72 % increase in brachial diameter STANDARD_DEVIATION 2.31 • n=5 Participants
Depressive Symptoms	1.86 Score on a scale STANDARD_DEVIATION 0.76 • n=5 Participants	1.96 Score on a scale STANDARD_DEVIATION 0.68 • n=7 Participants	1.91 Score on a scale STANDARD_DEVIATION 0.72 • n=5 Participants
High-Frequency Heart Rate Variability (HF HRV)	5.29 ln of ms^2/Hz STANDARD_DEVIATION 1.72 • n=5 Participants	5.15 ln of ms^2/Hz STANDARD_DEVIATION 1.66 • n=7 Participants	5.22 ln of ms^2/Hz STANDARD_DEVIATION 1.71 • n=5 Participants
Interleukin-6 (IL-6)	0.71 log10 of pg/ml STANDARD_DEVIATION 0.28 • n=5 Participants	0.75 log10 of pg/ml STANDARD_DEVIATION 0.27 • n=7 Participants	0.73 log10 of pg/ml STANDARD_DEVIATION 0.27 • n=5 Participants
High-Sensitivity C-Reactive Protein (hsCRP)	0.67 log10 of mg/l STANDARD_DEVIATION 0.40 • n=5 Participants	0.71 log10 of mg/l STANDARD_DEVIATION 0.40 • n=7 Participants	0.69 log10 of mg/l STANDARD_DEVIATION 0.40 • n=5 Participants
β-thromboglobulin	194 ng/ml STANDARD_DEVIATION 118 • n=5 Participants	213 ng/ml STANDARD_DEVIATION 108 • n=7 Participants	204 ng/ml STANDARD_DEVIATION 113 • n=5 Participants
Platelet Factor 4 (PF4)	4038 ng/ml STANDARD_DEVIATION 2047 • n=5 Participants	4290 ng/ml STANDARD_DEVIATION 2133 • n=7 Participants	4165 ng/ml STANDARD_DEVIATION 2094 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 195 of 216 randomized participants had post-treatment brachial FMD data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months	2.28 % increase in brachial diameter Standard Deviation 2.04	2.44 % increase in brachial diameter Standard Deviation 2.29

SECONDARY outcome

Timeframe: 12 months

Population: 200 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

Participants completed the reliable and valid Hopkins Symptom Checklist-20 (SCL-20) to assess depressive symptoms. Total scores (mean of items responses, range: 0-4) were computed, with higher scores indicating greater depressive symptoms.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Depressive Symptoms at 12 Months	1.12 Score on a scale Standard Deviation 0.80	1.65 Score on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: 12 months

Population: 190 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

HF HRV estimates were derived by spectral analysis (bandwidth: 0.15-0.40 Hz) from 1-minute epochs of electrocardiographic data obtained during the last 5 min of the 10-minute supine rest period using MindWare Technologies HRV analysis software (version 3.1.2). Mean HF HRV was computed as the average of the five estimates. To control for respiration rate, participants completed a paced-breathing computer task set to 12 breaths/minute.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
High-Frequency Heart Rate Variability (HF HRV) at 12 Months	5.39 ln of ms^2/Hz Standard Deviation 1.85	5.35 ln of ms^2/Hz Standard Deviation 1.78

SECONDARY outcome

Timeframe: 12 months

Population: 195 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of IL-6.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Interleukin-6 (IL-6) at 12 Months	0.73 log10 of pg/ml Standard Deviation 0.26	0.77 log10 of pg/ml Standard Deviation 0.27

SECONDARY outcome

Timeframe: 12 months

Population: 196 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months	0.65 log10 of mg/l Standard Deviation 0.40	0.74 log10 of mg/l Standard Deviation 0.41

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
β-thromboglobulin at 12 Months	185 ng/ml Standard Deviation 125	205 ng/ml Standard Deviation 118

SECONDARY outcome

Timeframe: 12 months

Population: 195 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis.

Outcome measures

Outcome measures
Measure	eIMPACT n=107 Participants eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 Participants Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Platelet Factor 4 (PF4) at 12 Months	3842 ng/ml Standard Deviation 2011	4351 ng/ml Standard Deviation 2341

Adverse Events

eIMPACT

Serious events: 5 serious events

Other events: 3 other events

Deaths: 5 deaths

Usual Care

Serious events: 4 serious events

Other events: 1 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	eIMPACT n=107 participants at risk eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 participants at risk Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Psychiatric disorders Hospitalization for depression/suicidal ideation	1.9% 2/107 • Number of events 2 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.92% 1/109 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Psychiatric disorders Emergency department visit for depression/suicidal ideation	1.9% 2/107 • Number of events 3 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.92% 1/109 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Psychiatric disorders Suspected drug overdose	0.93% 1/107 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.92% 1/109 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Endocrine disorders Diabetic ketoacidosis	0.00% 0/107 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.92% 1/109 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Psychiatric disorders Study procedures, including depression treatment	0.00% 0/107 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.00% 0/109 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.

Other adverse events

Other adverse events
Measure	eIMPACT n=107 participants at risk eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers.	Usual Care n=109 participants at risk Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Psychiatric disorders Passive suicidal ideation	0.93% 1/107 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.92% 1/109 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Gastrointestinal disorders Diarrhea following study-initiated suicidal ideation	0.93% 1/107 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.00% 0/109 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Vascular disorders Petechiae on hand/wrist due to blood pressure cuff inflation during brachial FMD assessment	0.93% 1/107 • Number of events 1 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.	0.00% 0/109 • For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years. Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.

Additional Information

Jesse C. Stewart, PhD., Principal Investigator

Indiana University-Purdue University Indianapolis (IUPUI)

Phone: 317-274-6761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place