Clinical trial NCT04158219: Healthy Heart Habits
Official title: Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Coronary Syndrome
Depression
Keywords: Behavioral randomized control trial
Behavioral activation
Multiple health behavior change
Integrated care
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Twenty subjects will be given the intervention according to the treatment manual.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability Measured by the Client Satisfaction Questionnaire
timeFrame: At 12 weeks
measure: Treatment Engagement Measured by Sessions Attended
timeFrame: At 12 weeks
Secondary outcomes:
measure: Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments
timeFrame: At 12 weeks
measure: Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)
timeFrame: At 12 weeks
measure: Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)
timeFrame: At 12 weeks
measure: Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare
name: Andrew M Busch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gathright EC, Vickery KD, Ayenew W, Whited MC, Adkins-Hempel M, Chrastek M, Carter JK, Rosen RK, Wu WC, Busch AM. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. PLoS One. 2022 Feb 3;17(2):e0261490. doi: 10.1371/journal.pone.0261490. eCollection 2022.