Healthy Heart Habits (H^3)

Hennepin Healthcare

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Coronary Syndrome

Depression

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04158219

1R03HL136540

Details and patient eligibility

About

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 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.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ACS diagnosis (diagnosis of unstable angina, ST and non-ST elevation myocardial infarction) documented in medical record in the preceding 2-12 months
Current diagnosis of depression documented in medical record, OR clinically administered PHQ-9 score of 10 or greater documented in the medical record in the preceding 12 months, OR CES-D score greater than or equal to 10
current non-adherence to 1 or more of 4 more behavioral risk factors
willing to make immediate changes to one or more of the relevant behavioral risk factors
age of 18-75
lives within 1.5 hours of Hennepin Healthcare
fluent in English.

Exclusion criteria

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