Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04877197 · ClinicalTrials.gov registry record · Phase 3
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
A Phase 3 study of Depression and Cardiovascular Diseases, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04877197: Recruiting Phase 3 study of Depression and Cardiovascular Diseases, sponsored by VA Office of Research and Development.
NCT04877197 is a Phase 3 study of Depression and Cardiovascular Diseases that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 132 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04877197, a Phase 3 study of Depression and Cardiovascular Diseases, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
This measure of functioning assesses one's perceived ability to perform usual social roles and activities. Items are worded negatively in terms of perceived limitations and are reverse-coded with higher scores represent fewer limitations. Each of the 8 items are scored 1 to 5 and totaled raw scores are used to derive T-scores, scaled to US general population estimates. In addition to PROMIS general validation efforts, evidence for reliability, construct validity, and sensitivity to change with c
Conditions Studied
Interventions
- BEHAVIORAL BA-HT
- OTHER Standard Care
Study Locations (1)
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What NCT04877197 shows while recruiting
NCT04877197 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which BA-HT is the first listed.
NCT04877197 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04877197 about?
NCT04877197 is a clinical study titled "Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care". 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 w...
What is the current status of trial NCT04877197?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2022-01-17. Estimated completion is 2026-09-30.
What conditions does trial NCT04877197 study?
This clinical trial studies the following conditions: Depression, Cardiovascular Diseases.
What interventions are being tested in trial NCT04877197?
The interventions under investigation include: BA-HT (BEHAVIORAL), Standard Care (OTHER).
Who is sponsoring clinical trial NCT04877197?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04877197 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04877197's enrollment target sits among peer trials
132 282nd of 679 higher than 396 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
RECRUITING · Phase 3
-
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
RECRUITING · Phase 3
-
PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study
RECRUITING · Phase 3
-
Creatine for Depressed Male and Female Methamphetamine Users
RECRUITING · Phase 3
-
E-Mindfulness Approaches for Living After Breast Cancer
RECRUITING · Phase 3
-
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy