eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
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|ClinicalTrials.gov Identifier: NCT02458690|
Recruitment Status : Completed
First Posted : June 1, 2015
Results First Posted : October 14, 2020
Last Update Posted : September 27, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder Dysthymic Disorder Depressive Symptoms Cardiovascular Diseases Heart Diseases Coronary Artery Disease Stroke||Behavioral: Beating the Blues (BtB) Behavioral: Problem Solving Treatment in Primary Care (PST-PC) Drug: Antidepressant Medications Other: Usual Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||March 2021|
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)
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.
Behavioral: Problem Solving Treatment in Primary Care (PST-PC)
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.
Drug: Antidepressant Medications
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.
Active Comparator: 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.
Other: Usual Care
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 Name: Treatment As Usual (TAU)
- Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months [ Time Frame: 12 months ]Patients undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change (positive values=increase; negative values=decrease) in brachial diameter at either 60 or 90 seconds after cuff deflation.
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Primary care patients
- Age ≥ 50 years
- Current depressive disorder
- Elevated cardiovascular disease risk
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458690
|United States, Indiana|
|IUPUI Department of Psychology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Jesse C Stewart, Ph.D.||Indiana University-Purdue University Indianapolis (IUPUI)|
Documents provided by Jesse Stewart, Indiana University:
|Responsible Party:||Jesse Stewart, Professor of Psychology, Indiana University|
|Other Study ID Numbers:||
R01HL122245 ( U.S. NIH Grant/Contract )
|First Posted:||June 1, 2015 Key Record Dates|
|Results First Posted:||October 14, 2020|
|Last Update Posted:||September 27, 2021|
|Last Verified:||August 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Computerized and Telephonic Psychotherapy
Coronary Artery Disease
Depressive Disorder, Major
Arterial Occlusive Diseases
Selective Serotonin Reuptake Inhibitors
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs