RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-17
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04877197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Having experienced one of the ICD 10 I20-I25 CVD events:
  2. * 120 unstable angina
  3. * stable angina
  4. * 121 NSTEMI
  5. * STEMI
  6. * initial encounter
  7. * 122 NSTEMI
  8. * STEMI
  9. * subsequent encounter
  10. * 124 acute coronary syndrome
  11. * 125 coronary arteriosclerosis with angina and/or
  12. * 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
  13. * Discharged from the RHJ VAMC inpatient care facilities
  14. * Diagnosis of Major Depressive Disorder on the basis of the Structured Clinical Interview for DSM 5 (First, Williams, Karg, \& Spitzer, 2015)
  1. * Coronary Artery Bypass Grafting (CABG)
  2. * Having a household member who is already enrolled in the study
  3. * Active psychosis or significant dementia at screening
  4. * Suicidal ideation with clear intent
  5. * Current alcohol use disorder rated severe
  6. * Concurrent enrollment in another clinical trial for depression

Contacts and Locations

Study Contact

Ron E Acierno, PhD MS BA
CONTACT
(843) 789-7246
Ron.Acierno@va.gov

Principal Investigator

Ron E. Acierno, PhD MS BA
PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Ron E. Acierno, PhD MS BA, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-17
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-01-17
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Veterans
  • Mental Health
  • Veterans Health
  • Cardiovascular Diseases

Additional Relevant MeSH Terms

  • Depression
  • Cardiovascular Diseases