Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
Recruiting · NCT04877197 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston, South Carolina, United States