RecruitingPhase 3NCT04877197

Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care

Sponsor

VA Office of Research and Development

Enrollment

132 participants

Start Date

Jan 17, 2022

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Depression

Summary

The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants will receive either (1) twelve sessions of BA-HT or (2) standard best practices post CVD hospitalization care. Study participants will be 132 Veterans discharged from the Ralph H. Johnson VA Medical Center inpatient care facilities with CVD diagnoses corresponding to ICD 10 codes I20-I25 (120 unstable angina, stable angina; 121 NSTEMI, STEMI, initial encounter; 122 NSTEMI, STEMI, subsequent encounter; 124 acute coronary syndrome; 125 coronary arteriosclerosis with angina). They will be male or female, age 21 and above, and with approximately 40-50% minority representation. There will be assessment at baseline, 1 week post treatment, as well as 3 and 9-months post treatment. The investigators predict that BA-HT will more effectively increase social role and activity functioning, activity, mood and reduce 9-month re-hospitalization compared to current best-practices post-discharge care among patients scoring at least moderately depressed on the PROMIS Depression scale one week following hospital discharge for a CVD event.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether behavioral activation therapy — a type of therapy that helps people re-engage with meaningful activities — delivered by telehealth from home can improve depression and daily functioning in veterans who have had a cardiac event and were recently discharged from the hospital. **You may be eligible if...** - You have experienced a recent heart event (such as a heart attack, unstable angina, valve repair, pacemaker implant, or similar cardiac procedure) within the past 6 months - You have been discharged from the VA Medical Center's inpatient care - You have been diagnosed with major depressive disorder **You may NOT be eligible if...** - You had coronary artery bypass grafting (CABG) surgery - Someone else in your household is already enrolled in this study - You have active psychosis or significant memory/cognitive problems - You have suicidal thoughts with a clear plan - You have severe alcohol use disorder - You are already in another clinical trial for depression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALBA-HT

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.

OTHERStandard Care

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.