NCT04158219

Healthy Heart Habits

Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.

Detailed description

Depression predicts high rates of morbidity/mortality among acute coronary syndrome (ACS) patients. Part of this relationship is explained by a poor profile of behavioral risk factors (i.e., smoking,physical activity, medication adherence, diet). An integrated treatment targeting both depressed mood and multiple behavioral risk factors could be highly effective in reducing post-ACS mortality. Behavioral Activation for depression may be an ideal counseling treatment for this since it has recently shown promise for facilitating behavioral risk factor changes in ACS patients with depression (K23HL107391). The current study adapts this manual targeting post-ACS depressed mood and smoking cessation to target depression and multiple behavioral risk factors post-ACS. This study will be an open trial (N=20) to test the feasibility and acceptability of our procedures and obtain initial indications of efficacy. This study hypothesizes that 1) the BA-HD manual and study procedures will be feasible and acceptable to post-ACS patients with depressed mood as measured by self-report, recruitment/retention rate, and post- treatment qualitative interviews and 2) that participants will experience clinically significant improvements in depressed mood and behavioral risk factor profile. The long-term goal of this research is to improve long-term survival rates following ACS.

Conditions

• Acute Coronary Syndrome
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral activation for health and depression (BA-HD)	Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes).

Timeline

• Start date: 2019-11-15
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2019-11-08
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

1 site across 1 country: United States