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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether depression therapy called Behavioral Activation, given through telehealth at home, helps Veterans with heart disease improve daily activities and social life. It is for Veterans age 21 or older with depression who recently left the hospital after heart care. Participants receive either 12 therapy sessions or usual care after a heart-related hospital stay.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a Veteran age 21 or older.
  • Have left inpatient care at the Ralph H. Johnson VA Medical Center.
  • Have major depression diagnosed through a structured interview.
  • Have a listed heart condition or procedure: chest pain from poor blood flow to the heart, a heart attack, other sudden loss of blood flow to the heart, or hardened heart arteries with chest pain; or one of the procedures below.
  • Qualifying procedures include heart valve repair or replacement, including TAVI/TAVR (valve replacement through a thin tube).
  • Qualifying procedures also include a pacemaker, implanted defibrillator (a device that corrects dangerous heart rhythms), or left ventricular assist device (a heart pump), placed in the past 6 months.
  • Other qualifying procedures include ablation (treatment for an abnormal heart rhythm) or a Watchman implant.

Who can't join

  • Have had coronary artery bypass surgery, which creates a new path for blood to reach the heart.
  • Live with someone already enrolled in this study.
  • Have active psychosis (trouble knowing what is real) or serious dementia (problems with memory and thinking) at screening.
  • Have thoughts of suicide with a clear intent to act.
  • Currently have severe alcohol use disorder.
  • Are also enrolled in another clinical trial for depression.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

SC