NCT06440278

Healthy Heart Habits-2

Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Acute coronary syndrome (ACS) represents a significant public health burden, with the most recent estimates suggesting that over 1 million U.S. adults experience ACS per year. As individuals are acutely surviving ACS more often, the associated disease burden is increasing for both the healthcare system and the individual living post-ACS. Poor engagement in health behaviors post-ACS contributes to risk for recurrent ACS and mortality. Modifiable behavioral contributors include smoking, medication non-adherence, physical inactivity, and poor diet. Approximately 20% of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors, which in turn, increases subsequent progression of cardiovascular disease. Treatment of depression alone improves, but does not eliminate, behavioral nonadherence. Behavioral Activation is a robust counseling treatment for depression with evidence of improvements in depressive symptoms across varied populations (including those with medication conditions). BA seeks to improve mood by increasing environmental reinforcement through collaborative, values-guided setting of "activation goals." The goal setting focus and structure of BA allows for seamless integration of health behavior targets and thus offers a potential framework to integrate depression and health behavior treatment. BA-HD may be a useful strategy to depression and multiple health behavior improvement post-ACS. However, this possibility requires further testing. The purpose of this study is to examine the feasibility and acceptability of a multisite pilot randomized controlled trial and test the initial potential effects of the intervention (BA-HD) on cardiovascular health and depressive symptoms relative to an Enhanced Usual Care control condition. Participants will be randomly assigned to either 12 weeks of tele-delivered BA-HD) or Enhanced Usual Care (i.e., one session of depression and heart disease education and provision of community mental health resources). Primary endpoints are feasibility of multisite recruitment procedures (e.g., recruitment rates at each site), feasibility of intervention and control procedures (e.g., percent of enrolled participants who complete the study), study retention (e.g., percent of participants who complete 3 month follow-up), and acceptability of intervention content and intervention delivery and control procedures. The investigators hypothesize that the intervention content and delivery will be 1) feasible and 2) acceptable. The investigators will also examine changes in cardiovascular health, depressive symptoms, medication adherence, affect, and quality of life.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Activation for Health and Depression (BA-HD)	BA-HD includes 8 - 10 sessions delivered over 10-12 weeks. Sessions use behavioral activation techniques to connect patient core values with goal-setting targeting activities that improve mood, alongside personalized adjustments to cardiovascular health behaviors (i.e., tobacco cessation, medication adherence, physical activity, diet, and sleep). Educational materials and commercially available tools like activity trackers, pillboxes, and portion control aids will accompany the goal-setting process to facilitate behavior change.
OTHER	Enhanced Usual Care	Patients will receive depression and heart disease education, as well as a list of local mental health resources.

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-04-30
• Completion: 2026-07-15
• First posted: 2024-06-03
• Last updated: 2026-01-27

Locations

3 sites across 1 country: United States