Behavioral Activation Teletherapy for Cardiovascular Disease
(VA HEART Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: CABG, Active psychosis, Severe alcohol use, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345Is 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.
678910How 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.
124511Eligibility 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.
+10 more
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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: BA-HTExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, SC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. [2023]Behavioral activation (BA) is effective for the treatment of depression. The Health Action Process Approach (HAPA), which is derived from health psychology, can provide a motivational-volitional framework of BA.
Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. [2022]Research analyzing behavioral activation (BA) teletherapy outcomes is limited. Among low-income real-world primary care patients receiving a brief BA teletherapy program for depression and anxiety, we analyzed descriptive statistics and changes in depression and anxiety scores throughout treatment.
Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. [2021]Behavioral activation is ideal for embedded behavioral health providers (BHPs) working in primary care settings treating patients reporting a range of depressive symptoms. The current study tested whether a brief version of Behavioral Activation (two 30-minute appointments, 2 boosters) designed for primary care (BA-PC) was more effective than primary care behavioral health treatment-as-usual (TAU) in reducing depressive symptoms and improving quality of life and functioning.
Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]Behavioral activation (BA) is receiving renewed interest as a stand-alone or as a component of cognitive-behavior therapy (CBT) for depression. However, few studies have examined which aspects of BA are most contributory to its efficacy.
Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]Behavioral activation is a pen and paper-based therapy form for treating depression. The patient registers their activity hourly, and together with the therapist, they agree on a plan to change behavior. However, with the limited clinical personnel, and a growing patient population, new methods are needed to advance behavioral activation.
Treatment of depression in patients with heart disease. [2022]There is a growing body of evidence that depression significantly and adversely affects cardiovascular health. Perhaps the most prominent finding is the documented increase in mortality rate in patients with depression after myocardial infarction. The critical questions of interest to both the clinician and researcher are whether there are safe and effective treatments for depression in patients with heart disease and whether treatment of depression reduces the increased risk of cardiac morbidity and mortality. Though the data are limited and are primarily from open or comparator trials, the tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and specific psychotherapies appear to be effective for treatment of depression in patients with ischemic heart disease (IHD), and response rates are comparable to those reported in depressed patients without heart disease; however, there has been only one placebo-controlled trial to date, and therefore it is premature to come to definitive conclusions regarding the efficacy of antidepressant therapies in this patient population. With respect to safety, the TCAs are associated with documented adverse cardiovascular effects, including increases in heart rate, orthostatic hypotension, and conduction delays. Use of TCAs in patients with IHD carries a proven increased risk of cardiac morbidity and perhaps of mortality as well. The SSRIs appear to be relatively safe and effective treatment for depression in patients with comorbid IHD.
Treatment of affective disorders in cardiac disease. [2019]Patients with cardiovascular disease (CVD) commonly have syndromal major depression, and depression has been associated with an increased risk of morbidity and mortality. Prevalence of depression is between 17% and 47% in CVD patients. Pharmacologic and psychotherapeutic interventions have long been studied, and in general are safe and somewhat efficacious in decreasing depressive symptoms in patients with CVD. The impact on cardiac outcomes remains unclear. The evidence from randomized controlled clinical trials indicates that antidepressants, especially selective serotonin uptake inhibitors, are overwhelmingly safe, and likely to be effective in the treatment of depression in patients with CVD. This review describes the prevalence of depression in patients with CVD, the physiological links between depression and CVD, the treatment options for affective disorders, and the clinical trials that demonstrate efficacy and safety of antidepressant medications and psychotherapy in this patient population. Great progress has been made in understanding potential mediators between major depressive disorder and CVD--both health behaviors and shared biological risks such as inflammation.
Psychological and Psychopharmacological Interventions in Psychocardiology. [2022]Patients with mental disorders have an increased risk to develop cardiovascular disease (CVD), and CVD are frequently comorbid with especially adjustment, anxiety and depressive disorders. Therefore, clinicians need to be aware of effective and safe psychological and pharmacological treatment strategies for patients with comorbid CVD and mental disorders. Cognitive behavioral therapy and third-wave of cognitive-behavioral therapy are effective for patients with CVD and mental disorders. Internet-based psychological treatments may also be considered. In more severe cases, psychopharmacological drugs are frequently used. Although generally well tolerated and efficacious, drug- and dose-dependent side effects require consideration. Among antidepressants, selective serotonin reuptake inhibitors, selective serotonin and noradrenalin reuptake inhibitors, and newer antidepressants, such as mirtazapine, bupropion, agomelatine, and vortioxetine, can be considered, while tricyclic antidepressants should be avoided due to their cardiac side effects. Mood stabilizers have been associated with arrhythmias, and some first- and second-generation antipsychotics can increase QTc and metabolic side effects, although substantial differences exist between drugs. Benzodiazepines are generally safe in patients with CVD when administered short-term, and may mitigate symptoms of acute coronary syndrome. Laboratory and ECG monitoring is always recommended in psychopharmacological drug-treated patients with CVD. Presence of a heart disease should not exclude patients from necessary interventions, but may require careful risk-benefit evaluations. Effectively and safely addressing mental disorders in patients with CVD helps to improve both conditions. Since CVD increase the risk for mental disorders and vice versa, care providers need to screen for these common comorbidities to comprehensively address the patients' needs.
Bupropion and paroxetine differentially influence cardiovascular and neuroendocrine responses to stress in depressed patients. [2013]There exists a need to identify safe and effective treatments for depression in patients with coronary heart disease (CHD).
Pharmacologic treatment of depression in patients with heart disease. [2022]The relationship between depression and cardiovascular disease is complex and multifaceted. There is a growing body of evidence that depression significantly and adversely affects cardiovascular health. Perhaps the most prominent finding is the documented increase in mortality rate in patients with depression after myocardial infarction. The critical questions of interest to both the clinician and researcher are whether there are safe and effective treatments for depression in patients with heart disease and whether treatment of depression reduces the increased risk of cardiac morbidity and mortality. Although the data are limited and are primarily from open or comparator trials, the tricyclics (TCAs) and selective serotonin reuptake inhibitors (SSRI) are effective for treatment of depression in patients with ischemic heart disease (IHD), and response rates are comparable with those reported in depressed patients without heart disease. In terms of safety, the TCAs are associated with documented adverse cardiovascular effects, including increases in heart rate, orthostatic hypotension, and conduction delays. Use of TCAs in patients with IHD carries a proven increased risk of cardiac morbidity and perhaps of mortality as well. The SSRI appear to be relatively safe and effective in the treatment for depression in patients with comorbid IHD.
A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]Behavioral activation (BA) is an evidence-based treatment for depression which has attracted interest and started to accumulate evidence for other conditions when delivered face-to-face. Due to its parsimoniousness, it is suitable to be delivered via the Internet. The goal of this systematic review and meta-analysis was to examine evidence from randomized controlled trials (RCTs) to determine the efficacy of Internet-based BA and assess the quality of this evidence.