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NCT01605552 · ClinicalTrials.gov registry record · Phase 2
Beating the Blues for Your Heart
A Phase 2 study of Depression and Depressive Symptoms, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01605552: Completed Phase 2 study of Depression and Depressive Symptoms, sponsored by Indiana University.
NCT01605552 is a Phase 2 study of Depression and Depressive Symptoms that has completed, run by Indiana University. The registered enrollment target is 29 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605552, a Phase 2 study of Depression and Depressive Symptoms, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this clinical trial is to evaluate whether a computerized depression treatment, delivered before the onset of heart disease, reduces the risk of heart disease in the future. Participants in this trial will be primary care patients who are depressed but do not have a history of heart disease. Half of these patients will receive a standard treatment (usual care), and the other half will receive eight weeks of an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. To evaluate change in heart disease risk, the investigators will measure the functioning of the arteries using ultrasound before and after the treatment. It is hypothesized that patients who receive Beating the Blues® will show greater improvements in both depression and artery function than patients who receive standard treatment.
Primary Outcome
Patients will 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 in brachial diamet
Conditions Studied
Interventions
- OTHER Usual Care
- BEHAVIORAL Beating the Blues (BtB)
Study Locations (1)
Indiana
- Indiana University-Purdue University Indianapolis (IUPUI) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01605552 record still lists
NCT01605552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT01605552 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01605552 about?
NCT01605552 is a clinical study titled "Beating the Blues for Your Heart". The objective of this clinical trial is to evaluate whether a computerized depression treatment, delivered before the onset of heart disease, reduces the risk of heart disease in the future. Participants in this trial will be primary care patients who are depressed but do not have a history of heart...
What is the current status of trial NCT01605552?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2011-07. Estimated completion is 2012-12.
What conditions does trial NCT01605552 study?
This clinical trial studies the following conditions: Depression, Depressive Symptoms, Heart Disease, Coronary Artery Disease (CAD), Cardiovascular Disease (CVD).
What interventions are being tested in trial NCT01605552?
The interventions under investigation include: Usual Care (OTHER), Beating the Blues (BtB) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01605552?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01605552 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01605552's enrollment target sits among peer trials
29 576th of 679 higher than 99 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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.
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