DepressionPhase 2NCT02458690
eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
A Phase 2 study testing Beating the Blues (BtB), Problem Solving Treatment in Primary Care (PST-PC) and Antidepressant Medications in people with Depression and Major Depressive Disorder, run by Indiana University at 1 site in United States.
Trial summary
The objective of this randomized controlled trial is to evaluate whether the investigators modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of cardiovascular disease (CVD), reduces the risk of future CVD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Major Depressive Disorder, Dysthymic Disorder
- What is being tested?
- Beating the Blues (BtB), Problem Solving Treatment in Primary Care (PST-PC) and Antidepressant Medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care patients
- Age ≥ 50 years
- Current depressive disorder
- Elevated cardiovascular disease risk
Who cannot join
- History of clinical cardiovascular disease
- Presence of the following chronic disorders: HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or past-year cancer
- History of bipolar disorder or psychosis
- Continuous (e.g., daily) treatment for a systemic inflammatory condition (e.g., rheumatoid arthritis, lupus, Crohn's disease, and ulcerative colitis) in the past 3 months. Nonsteroidal anti-inflammatory drug (NSAID) use is allowed, given its high prevalence in the target population.
- Current use of anticoagulants (Aspirin and cholesterol and blood pressure medications are allowed)
- Acute risk of suicide
Show all 9Show fewer
- Severe cognitive impairment
- Current pregnancy
- Ongoing depression treatment with a psychiatrist outside of the Eskenazi Health/Midtown system (ongoing depression treatment with a Eskenazi Health/Midtown psychiatrist is allowed, as we will be able to collaborate and coordinate depression care)
Trial locations and contacts
1 site in 1 country.
United States1 site
IUPUI Department of Psychology
Indianapolis, Indiana, 46202
About this study
The objective of this randomized controlled trial is to evaluate whether the investigators modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary care patients who are depressed but do not have a history of CVD. Half of the participants will receive standard depression treatment in primary care (usual care), and the other half will receive one year of eIMPACT, a collaborative stepped care program including antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate change in CVD risk, the investigators will measure artery function using ultrasound before and after the 1-year treatment period. It is hypothesized that patients who receive the eIMPACT intervention will have greater improvements in artery function than patients who receive usual care.
Read the detailed description
Cardiovascular disease (CVD) is the number one killer of American men and women, and its economic burden is substantial and on the rise. Adults with depression are at elevated risk of CVD events and poor CVD prognosis. Unfortunately, past trials of depression treatments have not observed the anticipated cardiovascular benefits. A novel explanation for these null results is that the interventions in these trials, which all involved patients with preexisting CVD, were delivered too late in the natural history of CVD. To begin to evaluate our hypothesis that treating depression before clinical CVD onset could reduce CVD risk, the investigators are conducting a phase II randomized controlled trial of 216 primary care patients aged ≥ 50 years with a depressive disorder and CVD risk factors but no clinical CVD. Patients will be randomized to one year of eIMPACT, our modernized IMPACT intervention, or usual primary care for depression. eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based depression treatments consistent with patient preference. The investigator shave modernized our intervention by incorporating computerized cognitive-behavioral therapy and delivering other treatment components via telephone. Our central hypothesis is that eIMPACT will improve endothelial dysfunction, which is considered a barometer of CVD risk, in depressed adults by decreasing depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation. The investigators will test our central hypothesis by carrying out these specific aims: (1) to determine whether eIMPACT reduces the excess CVD risk of depressed patients (primary outcome: endothelial dysfunction; exploratory outcome: incident CVD events) and (2) to examine candidate mechanisms underlying the effect of eIMPACT on CVD risk (secondary outcomes: depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation). A positive trial would generate the mechanistic rationale, efficacy evidence, and effect size estimates needed to justify and design a multisite, event-driven, phase III trial to confirm eIMPACT's efficacy in reducing CVD risk. Demonstrating that depression treatment reduces CVD risk, the primary expected outcome of this line of research, would have a substantial positive impact. It would identify a novel target (depression) for CVD prevention efforts, and it would equip providers with a new disseminable and scalable tool (eIMPACT) to simultaneously treat depression and manage the CVD risk of a large cohort of high-risk patients. Collectively, these changes to clinical practice should translate into reduced CVD morbidity, mortality, and costs.
- Conditions
- Depression, Major Depressive Disorder, Dysthymic Disorder, Depressive Symptoms, Cardiovascular Diseases, Heart Diseases
- Being tested
- Beating the Blues (BtB), Problem Solving Treatment in Primary Care (PST-PC), Antidepressant Medications, Usual Care
- Keywords
- Primary Care, Older Adults, Computerized and Telephonic Psychotherapy, Cognitive-Behavioral Therapy, Antidepressant Medications
- Medical subject headings
- Depression, Depressive Disorder, Major, Dysthymic Disorder, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beating the Blues (BtB)Behavioural
Also called Cognitive-Behavioral Therapy (CBT), Computer-Based Psychotherapy
BTB is a widely used, empirically supported, stand-alone CBT program for depression designed for primary care patients and appropriate for adults with little computer experience and a 5th-6th grade reading level. BtB utilizes an interactive, multimedia format to deliver eight 50-minute, weekly therapy sessions. Although sessions are tailored to each patient's problems, general topics include challenging dysfunctional thoughts, activity scheduling, problem solving, graded exposure, task breakdown, sleep management, and relapse prevention. Patients are also assigned tailored homeworks that are customized to their needs and reviewed at the start of each session.
Problem Solving Treatment in Primary Care (PST-PC)Behavioural
Also called Cognitive-Behavioral Therapy (CBT), Telephonic Psychotherapy
PST-PC is a manualized, empirically supported CBT developed for use by healthcare professionals in primary care. The focus of the 6-10 30-minute sessions is teaching patients approaches for solving current problems contributing to depression. We are delivering PST-PC via telephone.
Antidepressant MedicationsDrug
Also called Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), Norepinephrine-Dopamine Reuptake Inhibitor (NDRI), Tetracyclic Antidepressant (TeCA)
The IMPACT treatment manual provides guidelines for using antidepressants, such as selecting a medication, titrating, switching to another medication, managing side effects, and avoiding drug interactions. To optimize eIMPACT for CVD risk reduction, we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These medications are FDA approved for the treatment of depression and are the safest from a cardiovascular perspective.
Usual CareOther
Also called Treatment As Usual (TAU)
Patients randomized to usual primary care for depression are informed of their depression diagnosis, encouraged to follow-up with their Eskenazi Health primary care provider, and provided a list of local mental health services. The patient's primary care provider will receive a letter indicating that their patient has a depressive disorder and was randomized to usual care. This letter also provides a list of local mental health services. Like those in the intervention group, usual care patients continue to have access to services that are part of usual care in the targeted systems. 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.
| Study group | Role | What they receive |
|---|---|---|
| eIMPACT | Experimental | 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. Receives: Behavioral: Beating the Blues (BtB); Behavioral: Problem Solving Treatment in Primary Care (PST-PC); Drug: Antidepressant Medications |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months
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.
Measured: 12 months
Secondary outcomes (6)
Depressive Symptoms at 12 Months
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.
Measured: 12 months
High-Frequency Heart Rate Variability (HF HRV) at 12 Months
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.
Measured: 12 months
Interleukin-6 (IL-6) at 12 Months
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.
Measured: 12 months
High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months
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 hsCRP.
Measured: 12 months
β-thromboglobulin at 12 Months
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 β-thromboglobulin.
Measured: 12 months
Platelet Factor 4 (PF4) at 12 Months
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 PF4.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jesse Stewart, Indiana University
- Investigators
- Jesse C Stewart, Ph.D., Principal investigator, Indiana University-Purdue University Indianapolis (IUPUI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458690
- Sponsor's protocol ID
- 1411802537
- Other IDs
- R01HL122245
- Status last verified
- Oct 2023
- First submitted
- 28 May 2015
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Williams MK, Shell AL, Wu W, MacDonald KL, Callahan CM, Nurnberger JI Jr, Crawford CA, Schuiling MD, Stewart JC. Longer-term effects of modernized collaborative care for depression on multiple mental health factors (eIMPACT): A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120272. doi: 10.1016/j.jad.2025.120272. Epub 2025 Sep 8.
PubMed 40930184Schuiling MD, Wu W, Polanka BM, Shell AL, Williams MK, Crawford CA, MacDonald KL, Nurnberger JI Jr, Callahan CM, Stewart JC. Effect of depression treatment on subjective sleep components among primary care patients: Data from the eIMPACT trial. J Mood Anxiety Disord. 2025 Jun 3;11:100132. doi: 10.1016/j.xjmad.2025.100132. eCollection 2025 Sep.
PubMed 40822596Schuiling MD, Shell AL, Callahan CM, Nurnberger JI Jr, MacDonald KL, Considine RV, Wu W, Hirsh AT, Crawford CA, Williams MK, Lipuma TC, Gupta SK, Kovacs RJ, Rollman BL, Stewart JC. Effect of depression treatment on health behaviors and cardiovascular risk factors in primary care patients with depression and elevated cardiovascular risk: data from the eIMPACT trial. Psychol Med. 2024 Sep;54(12):3303-3316. doi: 10.1017/S0033291724001429. Epub 2024 Sep 10.
PubMed 39252547Crawford CA, Williams MK, Shell AL, MacDonald KL, Considine RV, Wu W, Rand KL, Stewart JC. Effect of modernized collaborative care for depression on brain-derived neurotrophic factor (BDNF) and depressive symptom clusters: Data from the eIMPACT trial. Psychiatry Res. 2023 Dec;330:115581. doi: 10.1016/j.psychres.2023.115581. Epub 2023 Oct 30.
PubMed 37931480Stewart JC, Patel JS, Polanka BM, Gao S, Nurnberger JI, MacDonald KL, Gupta SK, Considine RV, Kovacs RJ, Vrany EA, Berntson J, Hsueh L, Shell AL, Rollman BL, Callahan CM. Effect of modernized collaborative care for depression on depressive symptoms and cardiovascular disease risk biomarkers: eIMPACT randomized controlled trial. Brain Behav Immun. 2023 Aug;112:18-28. doi: 10.1016/j.bbi.2023.05.007. Epub 2023 May 18.
PubMed 37209779Shell AL, Gonzenbach V, Sawhney M, Crawford CA, Stewart JC. Associations between affective factors and high-frequency heart rate variability in primary care patients with depression. J Psychosom Res. 2022 Oct;161:110992. doi: 10.1016/j.jpsychores.2022.110992. Epub 2022 Jul 22.
PubMed 35917659
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
- ClinicalTrials.gov ID
- NCT02458690
- Acronym / sponsor ID
- 1411802537
- Conditions
- Depression, Major Depressive Disorder, Dysthymic Disorder, Depressive Symptoms, Cardiovascular Diseases, Heart Diseases
- Keywords
- Primary Care, Older Adults, Computerized and Telephonic Psychotherapy, Cognitive-Behavioral Therapy, Antidepressant Medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized controlled trial is to evaluate whether the investigators modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary care patients who are depressed but do not have a history of CVD. Half of the participants will receive standard depression treatment in primary care (usual care), and the other half will receive one year of eIMPACT, a collaborative stepped care program including antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate change in CVD risk, the investigators will measure artery function using ultrasound before and after the 1-year treatment period. It is hypothesized that patients who receive the eIMPACT intervention will have greater improvements in artery function than patients who receive usual care.
Detailed description
Cardiovascular disease (CVD) is the number one killer of American men and women, and its economic burden is substantial and on the rise. Adults with depression are at elevated risk of CVD events and poor CVD prognosis. Unfortunately, past trials of depression treatments have not observed the anticipated cardiovascular benefits. A novel explanation for these null results is that the interventions in these trials, which all involved patients with preexisting CVD, were delivered too late in the natural history of CVD. To begin to evaluate our hypothesis that treating depression before clinical CVD onset could reduce CVD risk, the investigators are conducting a phase II randomized controlled trial of 216 primary care patients aged ≥ 50 years with a depressive disorder and CVD risk factors but no clinical CVD. Patients will be randomized to one year of eIMPACT, our modernized IMPACT intervention, or usual primary care for depression. eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based depression treatments consistent with patient preference. The investigator shave modernized our intervention by incorporating computerized cognitive-behavioral therapy and delivering other treatment components via telephone. Our central hypothesis is that eIMPACT will improve endothelial dysfunction, which is considered a barometer of CVD risk, in depressed adults by decreasing depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation. The investigators will test our central hypothesis by carrying out these specific aims: (1) to determine whether eIMPACT reduces the excess CVD risk of depressed patients (primary outcome: endothelial dysfunction; exploratory outcome: incident CVD events) and (2) to examine candidate mechanisms underlying the effect of eIMPACT on CVD risk (secondary outcomes: depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation). A positive trial would generate the mechanistic rationale, efficacy evidence, and effect size estimates needed to justify and design a multisite, event-driven, phase III trial to confirm eIMPACT's efficacy in reducing CVD risk. Demonstrating that depression treatment reduces CVD risk, the primary expected outcome of this line of research, would have a substantial positive impact. It would identify a novel target (depression) for CVD prevention efforts, and it would equip providers with a new disseminable and scalable tool (eIMPACT) to simultaneously treat depression and manage the CVD risk of a large cohort of high-risk patients. Collectively, these changes to clinical practice should translate into reduced CVD morbidity, mortality, and costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eIMPACT | Experimental | Behavioral: Beating the Blues (BtB), Behavioral: Problem Solving Treatment in Primary Care (PST-PC), Drug: Antidepressant MedicationseIMPACT 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 | Active comparator | Other: Usual CarePatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary care patients
- Age ≥ 50 years
- Current depressive disorder
- Elevated cardiovascular disease risk
Key exclusion criteria (9 listed)
- History of clinical cardiovascular disease
- Presence of the following chronic disorders: HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or past-year cancer
- History of bipolar disorder or psychosis
- Continuous (e.g., daily) treatment for a systemic inflammatory condition (e.g., rheumatoid arthritis, lupus, Crohn's disease, and ulcerative colitis) in the past 3 months. Nonsteroidal anti-inflammatory drug (NSAID) use is allowed, given its high prevalence in the target population.
- Current use of anticoagulants (Aspirin and cholesterol and blood pressure medications are allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beating the Blues (BtB)Also: Cognitive-Behavioral Therapy (CBT), Computer-Based PsychotherapyBTB is a widely used, empirically supported, stand-alone CBT program for depression designed for primary care patients and appropriate for adults with little computer experience and a 5th-6th grade reading level. BtB utilizes an interactive, multimedia format to deliver eight 50-minute, weekly therapy sessions. Although sessions are tailored to each patient's problems, general topics include challenging dysfunctional thoughts, activity scheduling, problem solving, graded exposure, task breakdown, sleep management, and relapse prevention. Patients are also assigned tailored homeworks that are customized to their needs and reviewed at the start of each session. | Behavioural | eIMPACT |
| Problem Solving Treatment in Primary Care (PST-PC)Also: Cognitive-Behavioral Therapy (CBT), Telephonic PsychotherapyPST-PC is a manualized, empirically supported CBT developed for use by healthcare professionals in primary care. The focus of the 6-10 30-minute sessions is teaching patients approaches for solving current problems contributing to depression. We are delivering PST-PC via telephone. | Behavioural | eIMPACT |
| Antidepressant MedicationsAlso: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), Norepinephrine-Dopamine Reuptake Inhibitor (NDRI), Tetracyclic Antidepressant (TeCA)The IMPACT treatment manual provides guidelines for using antidepressants, such as selecting a medication, titrating, switching to another medication, managing side effects, and avoiding drug interactions. To optimize eIMPACT for CVD risk reduction, we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These medications are FDA approved for the treatment of depression and are the safest from a cardiovascular perspective. | Drug | eIMPACT |
| Usual CareAlso: Treatment As Usual (TAU)Patients randomized to usual primary care for depression are informed of their depression diagnosis, encouraged to follow-up with their Eskenazi Health primary care provider, and provided a list of local mental health services. The patient's primary care provider will receive a letter indicating that their patient has a depressive disorder and was randomized to usual care. This letter also provides a list of local mental health services. Like those in the intervention group, usual care patients continue to have access to services that are part of usual care in the targeted systems. 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. | Other | Usual Care |
Primary outcome
Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months
Time frame: 12 months
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.
6 secondary outcomes
Depressive Symptoms at 12 Months
Time frame: 12 months
High-Frequency Heart Rate Variability (HF HRV) at 12 Months
Time frame: 12 months
Interleukin-6 (IL-6) at 12 Months
Time frame: 12 months
High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months
Time frame: 12 months
β-thromboglobulin at 12 Months
Time frame: 12 months
Platelet Factor 4 (PF4) at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40930184Williams MK, Shell AL, Wu W, MacDonald KL, Callahan CM, Nurnberger JI Jr, Crawford CA, Schuiling MD, Stewart JC. Longer-term effects of modernized collaborative care for depression on multiple mental health factors (eIMPACT): A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120272. doi: 10.1016/j.jad.2025.120272. Epub 2025 Sep 8.
- Derived from this study: PubMed 40822596Schuiling MD, Wu W, Polanka BM, Shell AL, Williams MK, Crawford CA, MacDonald KL, Nurnberger JI Jr, Callahan CM, Stewart JC. Effect of depression treatment on subjective sleep components among primary care patients: Data from the eIMPACT trial. J Mood Anxiety Disord. 2025 Jun 3;11:100132. doi: 10.1016/j.xjmad.2025.100132. eCollection 2025 Sep.
- Derived from this study: PubMed 39252547Schuiling MD, Shell AL, Callahan CM, Nurnberger JI Jr, MacDonald KL, Considine RV, Wu W, Hirsh AT, Crawford CA, Williams MK, Lipuma TC, Gupta SK, Kovacs RJ, Rollman BL, Stewart JC. Effect of depression treatment on health behaviors and cardiovascular risk factors in primary care patients with depression and elevated cardiovascular risk: data from the eIMPACT trial. Psychol Med. 2024 Sep;54(12):3303-3316. doi: 10.1017/S0033291724001429. Epub 2024 Sep 10.
- Derived from this study: PubMed 37931480Crawford CA, Williams MK, Shell AL, MacDonald KL, Considine RV, Wu W, Rand KL, Stewart JC. Effect of modernized collaborative care for depression on brain-derived neurotrophic factor (BDNF) and depressive symptom clusters: Data from the eIMPACT trial. Psychiatry Res. 2023 Dec;330:115581. doi: 10.1016/j.psychres.2023.115581. Epub 2023 Oct 30.
- Derived from this study: PubMed 37209779Stewart JC, Patel JS, Polanka BM, Gao S, Nurnberger JI, MacDonald KL, Gupta SK, Considine RV, Kovacs RJ, Vrany EA, Berntson J, Hsueh L, Shell AL, Rollman BL, Callahan CM. Effect of modernized collaborative care for depression on depressive symptoms and cardiovascular disease risk biomarkers: eIMPACT randomized controlled trial. Brain Behav Immun. 2023 Aug;112:18-28. doi: 10.1016/j.bbi.2023.05.007. Epub 2023 May 18.
- Derived from this study: PubMed 35917659Shell AL, Gonzenbach V, Sawhney M, Crawford CA, Stewart JC. Associations between affective factors and high-frequency heart rate variability in primary care patients with depression. J Psychosom Res. 2022 Oct;161:110992. doi: 10.1016/j.jpsychores.2022.110992. Epub 2022 Jul 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse C Stewart, Ph.D. principal investigator
Indiana University-Purdue University Indianapolis (IUPUI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beating the Blues (BtB), Problem Solving Treatment in Primary Care (PST-PC) and Antidepressant Medications in people with Depression and Major Depressive Disorder, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458690, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.