DepressionVA HEARTNCT04877197
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
A study testing BA-HT in people with Depression and Cardiovascular Diseases, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Cardiovascular Diseases
- What is being tested?
- BA-HT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having experienced one of the ICD 10 I20-I25 CVD events:
- 120 unstable angina
- stable angina
- 121 NSTEMI
- STEMI
- initial encounter
Show all 14Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
Ron E Acierno, PhD MS BA, (843) 789-7246, Ron.Acierno@va.gov
Ron E. Acierno, PhD MS BA
About this study
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.
Read the 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:
- 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).
- To repeat these comparisons with sex and age as independent variables.
- 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.
- Conditions
- Depression, Cardiovascular Diseases
- Being tested
- BA-HT, Standard Care
- Keywords
- Veterans, Mental Health, Veterans Health, Cardiovascular Diseases
- Medical subject headings
- Depression, Cardiovascular Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA-HTBehavioural
Also called Behavioral Activation for depression delivered via home-based telehealth
Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.
Standard CareOther
Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.
| Study group | Role | What they receive |
|---|---|---|
| BA-HT | Experimental | Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software. Receives: Behavioral: BA-HT |
| Standard Care | Active comparator | Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Ability to Participate in Social Roles and Activities
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 cardiovascular surgery patients was provided by Flynn et al. (2015).
Measured: 13 weeks
PROMIS Satisfaction with Participation in Social Roles
This 8-item measure (items rated 1 to 5, higher scores corresponding to higher satisfaction), assesses satisfaction related to one's ability and performance of work, routine activities, and family activities and is responsive to change over time (Hahn et al., 2016). Thus, this measure complements purely functional assessment of capabilities with assessment of participant's impression of the quality their functioning.
Measured: 13 weeks
PROMIS Physical Function with Mobility Aid
This 11-item measure (high scores correspond to better mobility) is rated 1 to 5 (unable to do to "without any difficulty") and assesses self-report regarding many basic physical aspects of Activities of Daily Living. Both upper and lower extremity functioning is assessed, as well as instrumental activities.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start17 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ron E. Acierno, PhD MS BA, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877197
- Sponsor's protocol ID
- F3377-R
- Other IDs
- RX003377-01A2
- Acronym
- VA HEART
- Status last verified
- Jul 2026
- First submitted
- 3 May 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
- ClinicalTrials.gov ID
- NCT04877197
- Acronym / sponsor ID
- VA HEART / F3377-R
- Conditions
- Depression, Cardiovascular Diseases
- Keywords
- Veterans, Mental Health, Veterans Health, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- To repeat these comparisons with sex and age as independent variables.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BA-HT | Experimental | Behavioral: BA-HTBehavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software. |
| Standard Care | Active comparator | Other: Standard CareBest practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Having experienced one of the ICD 10 I20-I25 CVD events:
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BA-HTAlso: Behavioral Activation for depression delivered via home-based telehealthBehavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software. | Behavioural | BA-HT |
| Standard CareBest practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery. | Other | Standard Care |
Primary outcome
PROMIS Ability to Participate in Social Roles and Activities
Time frame: 13 weeks
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 cardiovascular surgery patients was provided by Flynn et al. (2015).
PROMIS Satisfaction with Participation in Social Roles
Time frame: 13 weeks
This 8-item measure (items rated 1 to 5, higher scores corresponding to higher satisfaction), assesses satisfaction related to one's ability and performance of work, routine activities, and family activities and is responsive to change over time (Hahn et al., 2016). Thus, this measure complements purely functional assessment of capabilities with assessment of participant's impression of the quality their functioning.
PROMIS Physical Function with Mobility Aid
Time frame: 13 weeks
This 11-item measure (high scores correspond to better mobility) is rated 1 to 5 (unable to do to "without any difficulty") and assesses self-report regarding many basic physical aspects of Activities of Daily Living. Both upper and lower extremity functioning is assessed, as well as instrumental activities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ron E. Acierno, PhD MS BA principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BA-HT in people with Depression and Cardiovascular Diseases, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ron E Acierno, PhD MS BA ((843) 789-7246, Ron.Acierno@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Ability to Participate in Social Roles and Activities (time frame: 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.