Telehealth Behavioral Activation for Veterans with Depression after Heart Issues
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
This study is testing whether a new home-based therapy for depression can help Veterans who have recently been treated for heart issues improve their daily functioning and recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04877197 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Behavioral Activation delivered via home-based telehealth (BA-HT) in improving social and role functioning among Veterans recently discharged from inpatient care for cardiovascular diseases. Participants will be randomly assigned to receive either twelve sessions of BA-HT or standard post-hospitalization care. The study will assess outcomes at baseline, one week post-treatment, and at three and nine months post-treatment, focusing on reducing functional impairment and enhancing recovery in depressed Veterans. The trial will involve 132 participants from the Ralph H. Johnson VA Medical Center.
Who should consider this trial
Good fit: Ideal candidates include Veterans aged 21 and above who have been recently discharged from inpatient care for specific cardiovascular conditions and diagnosed with Major Depressive Disorder.
Not a fit: Patients who have undergone coronary artery bypass grafting or have active psychosis or significant dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and overall functioning of Veterans recovering from cardiovascular events.
How similar studies have performed: Previous studies have shown promise in using telehealth for delivering mental health interventions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ron E. Acierno, PhD MS BA — Ralph H. Johnson VA Medical Center, Charleston, SC
- Study coordinator: Ron E Acierno, PhD MS BA
- Email: Ron.Acierno@va.gov
- Phone: (843) 789-7246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.