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

Trial Summary

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 data supports the effectiveness of the treatment Behavioral Activation for Health and Depression (BA-HD) for heart attack patients?

Behavioral Activation (BA) has been shown to be effective in treating depression by helping people engage in activities that improve their mood and motivation. While the research specifically on heart attack patients is not provided, the techniques used in BA, such as activity scheduling and skills training, have been supported as effective components in improving mental health, which could be beneficial for heart attack recovery. ^{1 2 3 4 5}

Is Behavioral Activation safe for humans?

Behavioral Activation has been used safely in various studies for treating depression and improving health behaviors in patients with heart conditions. While specific safety data is limited, it is generally considered safe as it involves structured activities and planning with a therapist. ^{1 2 5 6 7}

How is the treatment Behavioral Activation for Health and Depression (BA-HD) different from other treatments for heart attack recovery?

Behavioral Activation for Health and Depression (BA-HD) is unique because it combines strategies to improve mood and change health behaviors, specifically targeting both depression and heart health after a heart attack. This integrated approach is different from traditional treatments that may focus solely on physical recovery or mental health separately. ^{1 2 5 6 8}

What is the purpose of this trial?

Sixty adults who have experienced acute coronary syndrome within the past 2-12 months from three states (Rhode Island, North Carolina, Minnesota) will be randomized to either (1) a coaching program for depressed mood and health behavior change (Behavioral Activation for Health and Depression; BA-HD), or (2) Enhanced Usual Care. This study will evaluate the feasibility and acceptability of study procedures and BA-HD, and establish protocol and measurement harmonization across three sites in preparation for a future multi-site efficacy trial.

Research Team

Andrew Busch, PhD

Principal Investigator

Hennepin Healthcare Research Institute

Emily Gathright, PhD

Principal Investigator

The Miriam Hospital

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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]

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 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]

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]

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. 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]

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

What is behavioral activation? A review of the empirical literature. [2022]

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

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

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

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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]