Clinical trial NCT04877197: Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
Official title: Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depression
Cardiovascular Diseases
Keywords: Veterans
Mental Health
Veterans Health
Cardiovascular Diseases
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-05-07
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will use a 2x4 (treatment by time) repeated measures RCT crossover design (baseline, post-treatment, 3 \& 9-month follow-up; crossover for standard treatment group at 9 months). At the 9 month point, the comparison group will have the option of receiving the intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Following hospital discharge, risk of depression is significantly increased in cardio-vascular disease (CVD) patients. Moreover, CVD patients with depression face reduced functioning, increased morbidity and mortality, and diminished quality of life. Unfortunately, most depressed CVD patients do not receive appropriate evidence-based care for their depression, often because they are unable to, or fearful of travelling to providers for the regimen of 8-12 weekly visits of evidence-based psychotherapy such as Behavioral Activation (BA). The group developed, evaluated and subsequently implemented in VA clinics, the first VA program to use home based telehealth to deliver BA for depression to elderly Veterans. The investigators now propose to evaluate the ability of this evidence based treatment and delivery model (BA for depression via home-telehealth) to reduce functional impairment and improve recovery in depressed Veterans who have experienced a CVD event-related hospitalization.

The specific aims of this project are:

1. To compare effectiveness of Behavioral Activation for depression delivered via Home-based Telehealth- to standard post-CVD hospital discharge best-practices care in a 2x4 (treatment by time) repeated measures RCT crossover design (baseline, post-treatment, 3 \& 9-month follow-up; crossover for standard treatment group at 9 months) with 132 CVD Veteran patients evincing depression in terms of central outcomes of functioning (PROMIS Functioning and Global Health scales) and emotional symptoms (PROMIS Depression and Anxiety scales) and secondary objective outcomes related to activity (actigraphy data). At the 9 month point, the comparison group will have the option of receiving the intervention (thus complementing the RCT with a crossover phase).
2. To repeat these comparisons with sex and age as independent variables.
3. To evaluate BA-HT with respect to its effects on exploratory outcomes, including re-hospitalization.

The investigators predict that evidence-based psychotherapy for depression (i.e., Behavioral Activation) delivered via home based telehealth will more effectively increase social role and activity functioning, activity, mood and reduce 6-month re-hospitalization (exploratory hypothesis), 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.

If effective, this innovative treatment and delivery strategy will enhance global functioning, improve quality of life, and reduce costs to Veterans and the VA. Importantly, the proposed strategy leverages existing VA infrastructure and capabilities so that BA-HT could be immediately offered throughout VA as a preventative measure to enhance resiliency.

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

Primary outcomes:
measure: PROMIS Ability to Participate in Social Roles and Activities
timeFrame: 13 weeks
measure: PROMIS Satisfaction with Participation in Social Roles
timeFrame: 13 weeks
measure: PROMIS Physical Function with Mobility Aid
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Ron E. Acierno, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: