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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment BA-HT, Behavioral Activation Therapy, for cardiovascular disease?

Behavioral Activation Therapy has been shown to be effective in treating depression and anxiety, which are often linked to cardiovascular health. Studies have demonstrated that this therapy can reduce depressive symptoms and improve quality of life, suggesting potential benefits for patients with cardiovascular disease. ^{1 2 3 4 5}

Is Behavioral Activation Teletherapy safe for people with cardiovascular disease?

Psychological treatments, like cognitive behavioral therapy, are generally considered safe for people with cardiovascular disease. While specific safety data for Behavioral Activation Teletherapy isn't mentioned, similar therapies are usually well-tolerated. ^{6 7 8 9 10}

How is the Behavioral Activation Teletherapy treatment for cardiovascular disease different from other treatments?

Behavioral Activation Teletherapy is unique because it uses a structured approach to help patients engage in activities that improve mood and reduce depression, and it is delivered remotely, making it accessible for those who may not have easy access to in-person therapy. This approach is particularly novel for cardiovascular disease, as it focuses on mental health improvement, which can indirectly benefit heart health. ^{1 2 4 5 11}

Research Team

Ron E. Acierno, PhD MS BA

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

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 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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Treatment of affective disorders in cardiac disease. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Psychological and Psychopharmacological Interventions in Psychocardiology. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Bupropion and paroxetine differentially influence cardiovascular and neuroendocrine responses to stress in depressed patients. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of depression in patients with heart disease. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]