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Sixty adults who have experienced acute coronary syndrome within the past 2-12 months from three states (Rhode Island, North Carolina, Minnesota) will be randomized to either (1) a coaching program for depressed mood and health behavior change (Behavioral Activation for Health and Depression; BA-HD), or (2) Enhanced Usual Care. This study will evaluate the feasibility and acceptability of study procedures and BA-HD, and establish protocol and measurement harmonization across three sites in preparation for a future multi-site efficacy trial.
Acute coronary syndrome (ACS) represents a significant public health burden, with the most recent estimates suggesting that over 1 million U.S. adults experience ACS per year. As individuals are acutely surviving ACS more often, the associated disease burden is increasing for both the healthcare system and the individual living post-ACS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation for Health and Depression | Experimental |
| |
| Enhanced Usual Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation for Health and Depression (BA-HD) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility | Number of participants randomized per month of recruitment | Baseline |
| Study retention | Proportion of randomized participants who complete the 6 month assessment. | Week 26 |
| Treatment engagement | Dose of treatment received (i.e., session attendance) | Week 13 |
| Treatment Acceptability | Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction. | Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Health | Life's Essential 8 (LE8) Score; The LE8 classifies cardiovascular (CV) health across eight CV risk metrics: diet, physical activity, nicotine exposure, sleep health, weight, blood pressure, total cholesterol, and hemoglobin A1C. Each individual LE8 component is assigned a value ranging from 0 to 100. A total score is created by averaging each component score. Higher total scores reflect better overall CV health. |
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Inclusion Criteria:
Medical chart-documented ACS (diagnosis of unstable angina, ST or non-ST elevation myocardial infarction) occurrence within the past 2-12 months.
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Gathright, PhD | The Miriam Hospital | Principal Investigator |
| Andrew Busch, PhD | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | United States | ||
| ECU Health |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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|
| Enhanced Usual Care | Other | Patients will receive depression and heart disease education, as well as a list of local mental health resources. |
|
| Week 13, Week 26 |
| Depressive symptoms | Patient Health Questionnaire-9; Scores range from 0 to 27; higher scores indicate greater depressive symptoms. | Week 13, Week 26 |
| 7 Day Moderate to Vigorous Physical Activity | Minutes spent in moderate to vigorous physical activity from 7 day Actigraph wear | Week 13, Week 26 |
| Self-Reported Moderate to Vigorous Physical Activity | Minutes spent in moderate to vigorous physical activity over 7 days based on report from a 7 Day Physical Activity Recall interview | Week 13, Week 26 |
| Self-Reported Diet | Mediterranean Eating Pattern for Americans Questionnaire; Scores range from 0-16 with higher scores indicating greater consistency with mediterranean style diet | Week 13, Week 26 |
| 7-day point prevalence abstinence from smoking | Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed by carbon monoxide in a breath sample | Week 13, Week 26 |
| Sleep duration | Average hours of sleep per night over 7 nights assessed via 7 day Actigraph wear | Week 13, Week 26 |
| Self-reported sleep duration | Self-reported hours of sleep per night from the Pittsburgh Sleep Quality Index | Week 13, Week 26 |
| Body Mass Index | Body weight (kilograms)/ Height (meters squared) | Week 13, Week 26 |
| Blood pressure | Systolic and diastolic blood pressures (mmHg) | Week 13, Week 26 |
| Non-HDL cholesterol | mg/dL; measured via point of care testing | Week 13, Week 26 |
| Hemoglobin A1C | %; measured via point of care testing | Week 13, Week 26 |
| Medication adherence (cholesterol regimen) | DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to cholesterol medication; scores range from 1-5. | Week 13, Week 26 |
| Medication adherence (blood pressure regimen) | DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to blood pressure medication; scores range from 1-5 | Week 13, Week 26 |
| Medication adherence (blood glucose regimen) | DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to both oral and injectable medication (assessed separately) to manage blood glucose; scores range from 1-5 | Week 13, Week 26 |
| Major Adverse Cardiac Events | Composite of hospitalization for unstable angina, urgent coronary revascularization, and non-fatal myocardial infarction determined via participant inquiry and confirmed through electronic medical record review | Week 26 |
| All-cause mortality | Electronic medical record review | Week 26 |
| Health Behavior Engagement Composite | A health behavior engagement composite score will be created that follows the LE8 scoring structure. LE8 component scores will be summed for physical activity, diet, combustible tobacco exposure, and sleep. Medication adherence will also be assigned a score ranging from 0 to 100 based on scaled DOSE-Nonadherence scores. | Week 13, Week 26 |
| Greenville |
| North Carolina |
| 27835 |
| United States |
| The Miriam Hospital | Providence | Rhode Island | 02903 | United States |