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

NCT02458690 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1411802537R01HL122245
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Major Depressive Disorder; Dysthymic Disorder; Depressive Symptoms; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Stroke

Keywords

Primary Care; Older Adults; Computerized and Telephonic Psychotherapy; Cognitive-Behavioral Therapy; Antidepressant Medications

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Depressive Symptoms at 12 Months

  12 months

• High-Frequency Heart Rate Variability (HF HRV) at 12 Months

  12 months

• Interleukin-6 (IL-6) at 12 Months

  12 months

• High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months

  12 months

• β-thromboglobulin at 12 Months

  12 months

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Beating the Blues (BtB) BEHAVIORAL

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.

Also known as: Cognitive-Behavioral Therapy (CBT), Computer-Based Psychotherapy

eIMPACT

Problem Solving Treatment in Primary Care (PST-PC) BEHAVIORAL

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.

Also known as: Cognitive-Behavioral Therapy (CBT), Telephonic Psychotherapy

eIMPACT

Antidepressant Medications DRUG

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.

Also known as: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), Norepinephrine-Dopamine Reuptake Inhibitor (NDRI), Tetracyclic Antidepressant (TeCA)

eIMPACT

Usual Care OTHER

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.

Also known as: Treatment As Usual (TAU)

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care patients
• Age ≥ 50 years
• Current depressive disorder
• Elevated cardiovascular disease risk

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

IUPUI Department of Psychology

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

• 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.

  PMID: 40930184 DERIVED

• Schuiling 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.

  PMID: 40822596 DERIVED

• Schuiling 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 10:1-14. doi: 10.1017/S0033291724001429. Online ahead of print.

  PMID: 39252547 DERIVED

• Crawford 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.

  PMID: 37931480 DERIVED

• Stewart 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.

  PMID: 37209779 DERIVED

• Shell 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.

  PMID: 35917659 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Dysthymic Disorder; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Stroke

Interventions

Cognitive Behavioral Therapy; Primary Health Care; Selective Serotonin Reuptake Inhibitors; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Comprehensive Health Care; Patient Care Management; Health Services Administration; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Jesse C. Stewart, PhD., Principal Investigator
• Organization: Indiana University-Purdue University Indianapolis (IUPUI)

jstew@iupui.edu

317-274-6761

Study Officials

• Jesse C Stewart, Ph.D.

  Indiana University-Purdue University Indianapolis (IUPUI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: March 1, 2021
• Last Updated: October 19, 2023
• Results First Posted: October 14, 2020

Record last verified: 2023-10

Locations

US (1)