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Behavioral Activation Teletherapy for Cardiovascular Disease (HEART Trial)

Phase 3
Recruiting
Led By Ron E. Acierno, PhD MS BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
122 NSTEMI
124 acute coronary syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights

HEART Trial Summary

This trial will study whether a form of therapy called Behavioral Activation, delivered via home-based telehealth, is effective in improving social and role functioning in Veterans recently discharged from inpatient care for cardiovascular disease.

Who is the study for?
This trial is for Veterans aged 21+ who were recently discharged from inpatient care with certain types of cardiovascular disease (like unstable angina or coronary arteriosclerosis) and are diagnosed with Major Depressive Disorder. They can't join if they've had a recent bypass surgery, severe alcohol use disorder, active psychosis, significant dementia, intent to commit suicide, or if someone in their household is already enrolled.Check my eligibility
What is being tested?
The study tests whether Behavioral Activation via telehealth improves social functioning and mood in patients after hospital discharge for heart issues compared to standard post-hospitalization care. Participants will be randomly assigned to receive either twelve sessions of this therapy or the usual care.See study design
What are the potential side effects?
Since the intervention involves psychological therapy delivered through telehealth rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort during therapy.

HEART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a type of heart attack known as NSTEMI.
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I have had a recent heart attack or severe chest pain.
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I have been diagnosed with Major Depressive Disorder.
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I have had a severe heart attack.
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I have had a heart condition like angina or a heart attack.
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I have been diagnosed with Major Depressive Disorder.
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I have had a severe heart attack.
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I have had unstable angina.
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I have had a cardiovascular event like a heart attack.
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I have had a type of heart attack known as NSTEMI.
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I have heart disease with chest pain.
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My chest pain is consistent and manageable.

HEART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PROMIS Ability to Participate in Social Roles and Activities
PROMIS Physical Function with Mobility Aid
PROMIS Satisfaction with Participation in Social Roles

HEART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BA-HTExperimental Treatment1 Intervention
Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.
Group II: Standard CareActive Control1 Intervention
Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,873 Total Patients Enrolled
Ron E. Acierno, PhD MS BAPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
2 Previous Clinical Trials
305 Total Patients Enrolled

Media Library

BA-HT Clinical Trial Eligibility Overview. Trial Name: NCT04877197 — Phase 3
Cardiovascular Disease Research Study Groups: BA-HT, Standard Care
Cardiovascular Disease Clinical Trial 2023: BA-HT Highlights & Side Effects. Trial Name: NCT04877197 — Phase 3
BA-HT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04877197 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the long-term effects of BA-HT on patients?

"Our team at Power estimates that BA-HT is safe, as evidenced by its Phase 3 status. This means that there is data supporting its efficacy, as well as multiple rounds of data supporting its safety."

Answered by AI

How many people are choosing to participate in this research?

"That is accurate. The clinical trial in question, which is being conducted at a single site, is looking for 132 participants. The trial was first posted on 1/17/2022 and was last updated 3 days ago on 1/20/2022."

Answered by AI

Are we able to sign up for this research project yet?

"The latest information from clinicaltrials.gov is that this trial is looking for participants. The listing was first created on January 17th, 2022 and was last updated 3 days ago."

Answered by AI
~59 spots leftby Dec 2025