Behavioral Coaching for Heart Attack

(HHH-2 Trial)

Recruiting at 2 trial locations

Overseen By Kristen Walaska, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Cognitive impairment, Suicidality, Hearing impairment, others

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

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new coaching program called Behavioral Activation for Health and Depression (BA-HD) to assist individuals who have experienced a heart attack and are feeling down or struggling with healthy habits. The study compares two groups: one receives the new coaching, while the other receives their usual care with some enhancements. Eligible participants should have experienced a heart-related issue, such as a heart attack, in the last 2-12 months, frequently feel down, and need help with habits like smoking, exercise, or diet. The research aims to determine if the new program is user-friendly and well-received, paving the way for larger-scale testing. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative support programs for heart attack recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should be willing to make changes to their medication adherence if needed.

What prior data suggests that this coaching program is safe for heart attack patients?

Research shows that Behavioral Activation for Health and Depression (BA-HD) is generally easy for people to handle. Previous studies found that this therapy can reduce depression, which is crucial for heart health after a heart attack. In these studies, participants reported no serious side effects from the therapy itself. BA-HD aims to improve mood and encourage healthy habits, both vital for recovery. Although specific safety data for this exact program is unavailable, Behavioral Activation therapies have been tested before and are considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Activation for Health and Depression (BA-HD) approach because it takes a unique angle in tackling heart attack recovery. Unlike traditional treatments that focus solely on physical recovery, BA-HD emphasizes the connection between mental and physical health by actively engaging patients in behaviors that improve both. This method could lead to better overall recovery outcomes by addressing depression, which is often a hidden barrier to physical health improvement. By integrating mental health strategies directly into the recovery process, BA-HD has the potential to offer a more holistic and effective approach compared to standard care options, which typically don't focus as much on mental well-being.

What evidence suggests that Behavioral Activation for Health and Depression (BA-HD) might be an effective treatment for heart attack recovery?

Research has shown that Behavioral Activation for Health and Depression (BA-HD), which participants in this trial may receive, effectively reduces feelings of depression, anxiety, and stress. Improving mental health is crucial because people with depression often struggle to follow heart health advice after a heart attack. Studies have found that about half of heart attack patients experience emotional distress, affecting their recovery. Behavioral Activation is a type of therapy that encourages positive behavior changes and lifts mood. By focusing on both mental health and lifestyle changes, BA-HD aims to support better heart health outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Emily Gathright, PhD

Principal Investigator

The Miriam Hospital

Andrew Busch, PhD

Principal Investigator

Hennepin Healthcare Research Institute

Are You a Good Fit for This Trial?

This trial is for adults who've had an acute coronary syndrome event in the last 2-12 months. It's available in Rhode Island, North Carolina, and Minnesota. Participants should be willing to undergo a coaching program or receive enhanced usual care.

Inclusion Criteria

Resides within 90 minutes (driving time) of each site with no plans to relocate beyond that range during study participation

I had a heart attack between 2 to 12 months ago.

I have been feeling very down or depressed lately.

Exclusion Criteria

Suicidality

I am currently in a program for heart health or mental health improvement.

Chart indication of significant cognitive impairment (e.g., chart-documented dementia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either 12 weeks of tele-delivered BA-HD or Enhanced Usual Care

12 weeks

Tele-delivered sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Assessments at Week 13 and Week 26

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation for Health and Depression (BA-HD)

Trial Overview The study compares two approaches: Behavioral Activation for Health and Depression (BA-HD), which involves coaching for mood and health behavior changes, versus Enhanced Usual Care. The goal is to prepare for a larger future trial by testing these methods' practicality.

How Is the Trial Designed?

Group I: Behavioral Activation for Health and Depression Experimental Treatment 1 Intervention

Group II: Enhanced Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Published Research Related to This Trial

The Behavioral Activation for Health and Depression (BA-HD) treatment was developed to address both depression and health behaviors in patients recovering from acute coronary syndrome (ACS), showing high patient satisfaction with a mean score of 30.57 out of 32 in the Client Satisfaction Questionnaire.

In a pilot trial with eight participants, 88% completed the treatment, and there were promising improvements in both mood and health behaviors, suggesting that BA-HD could be an effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. Gathright, EC., Vickery, KD., Ayenew, W., et al.[2023]

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]

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]

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

Internet-based behavioral activation (iBA) significantly reduces depressive symptoms compared to inactive control groups, with a moderate effect size based on a systematic review of 12 randomized controlled trials involving 3274 participants.

iBA also leads to reductions in anxiety and improvements in quality of life and activation, although no significant effects on depressive symptoms were observed at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. Alber, CS., Krämer, LV., Rosar, SM., et al.[2023]

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]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613762/

Effectiveness of cognitive behavioral therapy-based ... Our findings suggest that CBT-based interventions were effective in reducing depression, anxiety, stress symptoms, and body mass index levels.

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

The development and pilot testing of a behavioral ... Patients with depression are less likely to follow recommendations to reduce cardiac risk during recovery from a myocardial infarction. Arch Intern Med ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001381

Post–Myocardial Infarction Psychological Distress Up to half of patients after myocardial infarction may experience some form of psychological distress, and this postmyocardial psychological ...

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

A randomized clinical trial of Behavioral Activation (BA) ... Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men, after controlling for other CVD risk factors (Ridker, ...

5. jmir.org jmir.org/2021/5/e25465/

U-CARE Heart Randomized Controlled Trial Twelve-Month ... Methods: Shortly after acute myocardial infarction, 239 patients (33% female, mean age 59.6 years) reporting mild-to-moderate symptoms of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06440278

Study Details | NCT06440278 | Healthy Heart Habits-2 Approximately 20% of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors, which in turn, ...

7. 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 ...