Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-06-13
2026-07-15
Brief Summary
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Detailed Description
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Poor engagement in health behaviors post-ACS contributes to risk for recurrent ACS and mortality. Modifiable behavioral contributors include smoking, medication non-adherence, physical inactivity, and poor diet. Approximately 20% of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors, which in turn, increases subsequent progression of cardiovascular disease. Treatment of depression alone improves, but does not eliminate, behavioral nonadherence. Behavioral Activation is a robust counseling treatment for depression with evidence of improvements in depressive symptoms across varied populations (including those with medication conditions). BA seeks to improve mood by increasing environmental reinforcement through collaborative, values-guided setting of "activation goals." The goal setting focus and structure of BA allows for seamless integration of health behavior targets and thus offers a potential framework to integrate depression and health behavior treatment. BA-HD may be a useful strategy to depression and multiple health behavior improvement post-ACS. However, this possibility requires further testing.
The purpose of this study is to examine the feasibility and acceptability of a multisite pilot randomized controlled trial and test the initial potential effects of the intervention (BA-HD) on cardiovascular health and depressive symptoms relative to an Enhanced Usual Care control condition. Participants will be randomly assigned to either 12 weeks of tele-delivered BA-HD) or Enhanced Usual Care (i.e., one session of depression and heart disease education and provision of community mental health resources).
Primary endpoints are feasibility of multisite recruitment procedures (e.g., recruitment rates at each site), feasibility of intervention and control procedures (e.g., percent of enrolled participants who complete the study), study retention (e.g., percent of participants who complete 3 month follow-up), and acceptability of intervention content and intervention delivery and control procedures. The investigators hypothesize that the intervention content and delivery will be 1) feasible and 2) acceptable. The investigators will also examine changes in cardiovascular health, depressive symptoms, medication adherence, affect, and quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Behavioral Activation for Health and Depression
Behavioral Activation for Health and Depression (BA-HD)
BA-HD includes 8 - 10 sessions delivered over 10-12 weeks. Sessions use behavioral activation techniques to connect patient core values with goal-setting targeting activities that improve mood, alongside personalized adjustments to cardiovascular health behaviors (i.e., tobacco cessation, medication adherence, physical activity, diet, and sleep). Educational materials and commercially available tools like activity trackers, pillboxes, and portion control aids will accompany the goal-setting process to facilitate behavior change.
Enhanced Usual Care
Enhanced Usual Care
Patients will receive depression and heart disease education, as well as a list of local mental health resources.
Interventions
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Behavioral Activation for Health and Depression (BA-HD)
BA-HD includes 8 - 10 sessions delivered over 10-12 weeks. Sessions use behavioral activation techniques to connect patient core values with goal-setting targeting activities that improve mood, alongside personalized adjustments to cardiovascular health behaviors (i.e., tobacco cessation, medication adherence, physical activity, diet, and sleep). Educational materials and commercially available tools like activity trackers, pillboxes, and portion control aids will accompany the goal-setting process to facilitate behavior change.
Enhanced Usual Care
Patients will receive depression and heart disease education, as well as a list of local mental health resources.
Eligibility Criteria
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Inclusion Criteria
* Post-ACS depressed mood defined as a Patient Health Questionnaire(PHQ)--9 score ≥ 10 upon screening,
* Non-adherence to and willingness to implement changes to ≥1 health behavior based on screening of:
1. Smoking/Tobacco exposure,
2. Physical Activity,
3. Diet,
4. Sleep health,
5. Medication adherence
* English-language fluency
* Resides within 90 minutes (driving time) of each site with no plans to relocate beyond that range during study participation
* Access to a telephone and/or videoconferencing capability
* Has primary care provider
* Address at which packages can be received
Exclusion Criteria
* Suicidality,
* Hearing impairment that prevents telephone/video communication for intervention and assessment purposes,
* Current hospice care, and
* Current engagement in cardiac rehabilitation or other regular counseling treatment targeting depression or health behavior change
18 Years
80 Years
ALL
No
Sponsors
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The Miriam Hospital
OTHER
Responsible Party
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Emily C. Gathright, PhD
Research Scientist
Principal Investigators
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Emily Gathright, PhD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Andrew Busch, PhD
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Locations
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Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
ECU Health
Greenville, North Carolina, United States
The Miriam Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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