Healthy Heart Habits
Condition: Acute Coronary Syndrome; Depression
MeSH terms: Acute Coronary Syndrome; Syndrome; Depression
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Behavioral activation for health and depression (BA-HD)
Intervention type(s): Behavioral
Intervention description(s): 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).
Intervention model: Single Group Assignment
Intervention model description: Twenty subjects will be given the intervention according to the treatment manual.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral randomized control trial; Behavioral activation; Multiple health behavior change; Integrated care