Healthy Heart Habits

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-02-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Twenty subjects will be given the intervention according to the treatment manual.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Behavioral activation for health and depression (BA-HD)

Group Type EXPERIMENTAL

Behavioral activation for health and depression (BA-HD)

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No