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NCT02458690 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Indiana University.

Completed
Registry status
Phase 2
Development phase
216
Enrollment target

NCT02458690: Completed Phase 2 study, sponsored by Indiana University.

NCT02458690 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 216 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02458690, a Phase 2 study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Phase 2
Development phase
216 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2015-07
Est. Completion 2021-03
Phase Phase 2
Indiana University

890 total trials

What the finished NCT02458690 record still lists

NCT02458690 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).

The record links to 0 conditions, and to 4 interventions - of which Usual Care is the first listed.

NCT02458690 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02458690 about?

NCT02458690 is a clinical study titled "eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients". 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...

What is the current status of trial NCT02458690?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2015-07. Estimated completion is 2021-03.

What interventions are being tested in trial NCT02458690?

The interventions under investigation include: Usual Care (OTHER), Beating the Blues (BtB) (BEHAVIORAL), Problem Solving Treatment in Primary Care (PST-PC) (BEHAVIORAL), Antidepressant Medications (DRUG).

Who is sponsoring clinical trial NCT02458690?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02458690's enrollment target sits among peer trials

216 286th of 2000 higher than 1,712 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02458690, the US trial registry maintained by the National Library of Medicine. NCT02458690 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.