Behavioral Activation Teletherapy for Cardiovascular Disease

(VA HEART Trial)

Overseen By Ron E Acierno, PhD MS BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: CABG, Active psychosis, Severe alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Behavioral Activation Teletherapy (BA-HT) to aid Veterans in recovering after hospitalization for heart-related issues. The goal is to determine if this therapy improves social and daily functioning compared to standard care methods. Participants will receive either 12 teletherapy sessions or the usual care after hospital discharge. The trial seeks Veterans who have recently experienced heart problems, such as angina or a heart attack, and are feeling moderately depressed. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Activation Therapy (BA) is generally easy for people to handle. Studies indicate that BA is as effective as antidepressants for treating depression, even in individuals with heart conditions, suggesting its safety for those with heart disease.

One study found that BA therapy might reduce depression and lower levels of IL-6, a marker linked to heart disease risk, without causing significant side effects. Another study on patients with acute coronary syndrome, a type of heart disease, found that BA could improve mood and reduce depression, again without major negative effects.

Overall, these findings suggest that BA is likely safe and well-tolerated for people with heart-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation Teletherapy for Cardiovascular Disease because it offers a novel approach to supporting mental health in patients who have experienced cardiovascular events. Unlike traditional in-person therapy or medication treatments for depression, this method delivers therapy via telehealth, allowing patients to receive care from the comfort of their homes. This delivery method not only makes therapy more accessible but also integrates mental health support into the recovery process from cardiovascular disease more seamlessly. By focusing on behavioral activation, this approach targets improving mood and activity levels, potentially enhancing recovery outcomes beyond standard care practices.

What evidence suggests that Behavioral Activation Teletherapy is effective for improving social and role functioning in Veterans with cardiovascular disease?

Research has shown that Behavioral Activation Therapy (BA) effectively treats depression in individuals with heart conditions. One study found that BA therapy reduces depression symptoms as effectively as antidepressants. This finding is significant because depression can worsen heart health. Another study found that BA therapy might lower levels of IL-6, a substance linked to heart disease risk. In this trial, participants in the BA-HT arm will receive Behavioral Activation for depression through home-based telehealth, potentially improving mood and social interactions in patients recovering from heart-related events. ^{3 4 6 7 8}

Who Is on the Research Team?

Ron E. Acierno, PhD MS BA

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans aged 21+ who were recently discharged from inpatient care with certain types of cardiovascular disease (like unstable angina or coronary arteriosclerosis) and are diagnosed with Major Depressive Disorder. They can't join if they've had a recent bypass surgery, severe alcohol use disorder, active psychosis, significant dementia, intent to commit suicide, or if someone in their household is already enrolled.

Inclusion Criteria

I have had a type of heart attack known as NSTEMI.

initial encounter

I have had a recent heart attack or severe chest pain.

Exclusion Criteria

Active psychosis or significant dementia at screening

I have had a heart bypass surgery.

Having a household member who is already enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation for depression delivered via home-based telehealth over 12 weekly sessions or standard best practices post-CVD hospitalization care.

12 weeks

12 visits (virtual for BA-HT group), weekly telephone calls for standard care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 week, 3 months, and 9 months post-treatment.

9 months

3 visits (virtual or in-person)

Crossover Phase

Participants in the standard care group have the option to receive the BA-HT intervention at the 9-month point.

Optional

What Are the Treatments Tested in This Trial?

Interventions

• BA-HT

Trial Overview The study tests whether Behavioral Activation via telehealth improves social functioning and mood in patients after hospital discharge for heart issues compared to standard post-hospitalization care. Participants will be randomly assigned to receive either twelve sessions of this therapy or the usual care.

How Is the Trial Designed?

Group I: BA-HT Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Depression is highly prevalent among patients with cardiovascular disease (CVD), affecting between 17% and 47% of this population, and is linked to increased morbidity and mortality.

Antidepressants, particularly selective serotonin reuptake inhibitors, are shown to be safe and likely effective in reducing depressive symptoms in CVD patients, although their impact on cardiac outcomes remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of affective disorders in cardiac disease. Mavrides, N., Nemeroff, CB.[2019]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

In a study of 130 low-income primary care patients receiving brief behavioral activation teletherapy for depression and anxiety, those who completed 4 or more sessions showed significantly lower depression and anxiety scores compared to those who completed fewer sessions.

The majority of patients achieved and maintained remission from depression, indicating that BA teletherapy is a feasible and effective treatment option for improving mental health outcomes in low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. Trombello, JM., South, C., Cecil, A., et al.[2022]

Depression significantly worsens cardiovascular health, particularly increasing mortality rates after heart attacks, highlighting the need for effective treatments in patients with heart disease.

While tricyclic antidepressants (TCAs) can be effective, they pose cardiovascular risks, making selective serotonin reuptake inhibitors (SSRIs) a safer and effective option for treating depression in patients with ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of depression in patients with heart disease. Roose, SP.[2022]

Cognitive behavioral therapy and internet-based psychological treatments are effective for patients with both cardiovascular disease (CVD) and mental disorders, highlighting the importance of psychological interventions in this population.

When pharmacological treatment is necessary, selective serotonin reuptake inhibitors and newer antidepressants are preferred due to their efficacy and safety, while tricyclic antidepressants should be avoided due to potential cardiac side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and Psychopharmacological Interventions in Psychocardiology. Kahl, KG., Stapel, B., Correll, CU.[2022]

A brief version of Behavioral Activation for primary care (BA-PC) was found to significantly improve quality of life and mental health functioning in veterans compared to standard treatment-as-usual (TAU) after 12 weeks, despite both groups showing reductions in depressive symptoms.

The study involved 140 veterans and demonstrated that BA-PC not only maintained reductions in depressive symptoms but also had better treatment retention and feasibility, suggesting it could be a valuable approach for managing depression in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. Funderburk, JS., Pigeon, WR., Shepardson, RL., et al.[2021]

In a study comparing 17 depressed patients on bupropion and 17 on paroxetine, both treatments showed reduced cardiovascular and neuroendocrine responses to stress compared to 15 unmedicated controls, indicating their potential effectiveness in managing depression in patients with coronary heart disease (CHD).

However, bupropion was associated with a less favorable autonomic profile, showing increased total peripheral resistance and norepinephrine levels, along with reduced heart rate variability, suggesting it may have more negative cardiovascular effects than paroxetine in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion and paroxetine differentially influence cardiovascular and neuroendocrine responses to stress in depressed patients. Straneva-Meuse, PA., Light, KC., Allen, MT., et al.[2013]

A study involving 128 participants with major depressive episodes found that a Health Action Process Approach (HAPA)-based internet-delivered behavioral activation intervention significantly reduced clinician-rated depressive symptoms compared to a control group, with a strong effect size at 8 weeks (d = 0.79).

The intervention group also showed improvements in self-rated depressive symptoms, behavioral activation, and various motivational and volitional outcomes, indicating that the HAPA framework effectively enhances treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. Mueller-Weinitschke, C., Bengel, J., Baumeister, H., et al.[2023]

Depression significantly worsens cardiovascular health, particularly increasing mortality rates after heart attacks, highlighting the need for effective treatment in patients with heart disease.

Selective serotonin reuptake inhibitors (SSRIs) are found to be safe and effective for treating depression in patients with ischemic heart disease, while tricyclic antidepressants (TCAs) pose risks of adverse cardiovascular effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of depression in patients with heart disease. Roose, SP., Miyazaki, M.[2022]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04877197

Behavioral Activation Delivered Via Home-based ... The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11552036/

Behavioral Activation Therapy for Depression Led by Health ... Overall, these findings support the effectiveness and applicability of behavioral activation therapy in treating depression in older adults.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796713001228

A randomized clinical trial of Behavioral Activation (BA) ... BA therapy showed promise for reducing depression and IL-6, a biomarker of CVD risk. •. This study is novel in showing efficacy of BA for psychological and ...

4. hcplive.com hcplive.com/view/behavioral-activation-therapy-treats-depression-patients-heart-failure

Behavioral Activation Therapy Treats Depression in ... A new study found behavioral activation therapy is just as effective as antidepressants for treating depressive symptoms in patients with heart ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814018

Comparative Effectiveness of Psychotherapy vs ... This comparative effectiveness randomized clinical trial compares the effectiveness of behavioral activation psychotherapy vs antidepressant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021889/

Efficacy and safety of behavioural activation on depression ... Six studies rated as low risk of bias. For short-term follow-ups (up to 6 months), meta-analysis showed behavioural activation had little effect on depression ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8812840/

The development and pilot testing of a behavioral ... Patients with acute coronary syndrome (ACS) with depressed mood demonstrate poor cardiovascular behavioral risk profiles and elevated risk for recurrent ACS ...

8. withpower.com withpower.com/trial/phase-3-cardiovascular-diseases-2022-c99c7

Behavioral Activation Teletherapy for Cardiovascular ... The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in ...