Healthy Heart Habits

Overview

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.

Full Title of Study: “Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2020

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 will adapted 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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Behavioral activation for health and depression (BA-HD)

Clinical Trial Outcome Measures

Primary Measures

  • Acceptability measured by the Client Satisfaction Questionnaire
    • Time Frame: At 12 weeks
    • This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire.
  • Treatment engagement measured by number of sessions attended
    • Time Frame: At 12 weeks
    • Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Secondary Measures

  • Study retention measured by percentage completion of assessments
    • Time Frame: At 12 weeks
    • Study retention will be tracked by measuring the percentage of participants who complete follow-up assessments.
  • Depression symptoms as measured by PHQ-9
    • Time Frame: At 12 weeks
    • Depression symptoms will be measured by Patient Health Questionnaire, 9-item.
  • Depression symptoms as measured by CES-D 10
    • Time Frame: At 12 weeks
    • Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale, 10- item.
  • Composite behavioral risk factor adherence
    • Time Frame: At 12 weeks
    • The Medical Outcomes Study Patient Adherence Questionnaire will be used to assess adherence to behavior change goals (10 items related to cardiac health will be scored).

Participating in This Clinical Trial

Inclusion Criteria

1) ACS diagnosis (diagnosis of unstable angina, ST and non-ST elevation myocardial infarction) documented in medical record in the preceding 2-12 months, 2) CES-D score greater than or equal to 10, 3) current non-adherence to or more of 4 more behavioral risk factors, 4) willing to make immediate changes to one or more of the relevant behavioral risk factors, 5) age of 18-75, 6) lives within 1.5 hours of Hennepin Healthcare, and 7) fluent in English.

Exclusion Criteria

1) Limited mental competency (as indicated in medical chart), 2) presence of current exacerbation of psychosis/serious mental illness or suicidality, 3) in hospice care, 4) currently attending regular counseling targeting depression or any health behavior change, and 5) currently attending a cardiac rehabilitation program (those excluded for being in rehabilitation will be re-contacted after completion).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hennepin Healthcare Research Institute.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew Busch, Sr. Clinical Psychologist, Associate Professor – Hennepin Healthcare Research Institute.
  • Overall Contact(s)
    • Andrew M Busch, PhD, 612-873-6681, Andrew.Busch@hcmed.org

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