← Back to Search

Behavioral Activation Teletherapy for Cardiovascular Disease (VA 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

124 acute coronary syndrome

STEMI

Must not have

Coronary Artery Bypass Grafting (CABG)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a recent heart attack or severe chest pain.

Select...

I have had a severe heart attack.

Select...

I have had a heart condition like angina or a heart attack.

Select...

I have been diagnosed with Major Depressive Disorder.

Select...

I have had unstable angina.

Select...

I have had a cardiovascular event like a heart attack.

Select...

I have heart disease with chest pain.

Select...

My chest pain is consistent and manageable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a heart bypass surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PROMIS Ability to Participate in Social Roles and Activities

PROMIS Physical Function with Mobility Aid

PROMIS Satisfaction with Participation in Social Roles

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 9Eligibility criteria met