MedPath

Healthy Heart Habits

Phase 1
Completed
Conditions
Acute Coronary Syndrome
Depression
Interventions
Behavioral: Behavioral activation for health and depression (BA-HD)
Registration Number
NCT04158219
Lead Sponsor
Hennepin Healthcare Research Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
8
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TreatmentBehavioral activation for health and depression (BA-HD)Behavioral activation for health and depression (BA-HD)
Primary Outcome Measures
NameTimeMethod
Acceptability Measured by the Client Satisfaction QuestionnaireAt 12 weeks

This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction.

Treatment Engagement Measured by Sessions AttendedAt 12 weeks

Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Secondary Outcome Measures
NameTimeMethod
Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)At 12 weeks

Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms.

Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)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. Items are rated on a 1-6 scale. Because not all items will be relevant to all participants, the average score across the relevant items for each participant will be presented. Higher scores indicating greater adherence to healthcare provider recommendations.

Study Retention Measured by the Number of Participants Who Complete the Follow-up AssessmentsAt 12 weeks

Study retention will be tracked by measuring the number of participants who complete the follow-up assessments

Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)At 12 weeks

Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale 10-item. Score range is 0-30 with higher scores indicating higher depression symptoms.

Trial Locations

Locations (1)

Hennepin Healthcare

🇺🇸

Minneapolis, Minnesota, United States

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