Recruiting

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

ClinicalTrials.gov IDNCT04877197

PhaseNA

Enrollment132

SponsorVA Office of Research and Development

Age21 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Cardiovascular Diseases

About this study

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 Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-elevation myocardial infarction (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.

Interventions

Behavioral: BA-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.
Other: Standard 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.

Primary outcomes

PROMIS Ability to Participate in Social Roles and Activities (13 weeks)
PROMIS Satisfaction with Participation in Social Roles (13 weeks)
PROMIS Physical Function with Mobility Aid (13 weeks)

Eligibility information

Inclusion Criteria: * Having experienced one of the ICD 10 I20-I25 CVD events: * 120 unstable angina * stable angina * 121 NSTEMI * STEMI * initial encounter * 122 NSTEMI * STEMI * subsequent encounter * 124 acute coronary syndrome * 125 coronary arteriosclerosis with angina and/or * Valve repair, valve replacement, Transcatheter Aortic Valve Implantation (TAVI/TAVR), Pacemaker Implantation in the past 6 months, Implantable Cardioverter Defibrillators (ICDs) in the past 6 months; Left Ventricular Assist Device in the past 6 months; Ablation Therapy; Watchman Implant; and * Discharged from the RHJ VAMC inpatient care facilities * Diagnosis of Major Depressive Disorder on the basis of the Structured Clinical Interview for DSM 5 (First, Williams, Karg, \& Spitzer, 2015) Exclusion Criteria: * Coronary Artery Bypass Grafting (CABG) * Having a household member who is already enrolled in the study * Active psychosis or significant dementia at screening * Suicidal ideation with clear intent * Current alcohol use disorder rated severe * Concurrent enrollment in another clinical trial for depression

Study locations

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina 29401-5703 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.