Who is sponsoring NCT02458690?

NCT02458690 is sponsored by Indiana University.

What condition does NCT02458690 study?

NCT02458690 studies Depression, Major Depressive Disorder, Dysthymic Disorder, Depressive Symptoms, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Stroke.

What drugs are being tested in NCT02458690?

Interventions: Beating the Blues (BtB), Problem Solving Treatment in Primary Care (PST-PC), Antidepressant Medications, Usual Care.

What is the status of NCT02458690?

NCT02458690 is currently COMPLETED.

Last reviewed 2023-10-03 · How we verify

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

NCT02458690 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Indiana University
Phase	Phase 2
Status	COMPLETED
Enrolment	216
Start date	2015-07
Completion	2021-03

Conditions

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

Interventions

Beating the Blues (BtB)
Problem Solving Treatment in Primary Care (PST-PC)
Antidepressant Medications
Usual Care

Primary outcomes

Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months — 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.

Countries

United States