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Completed

NCT Number: NCT06440278

Healthy Heart Habits-2

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare Research Institute, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Smoking/Tobacco exposure,
  • Physical Activity,
  • Diet,
  • Sleep health,
  • 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

  • Chart indication of significant cognitive impairment (e.g., chart-documented dementia), Current exacerbation of serious mental illness,
  • 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

Treatment and study plan

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.

Enhanced usual care

Other

Patients will receive depression and heart disease education, as well as a list of local mental health resources.

Primary outcomes

  1. Recruitment feasibility

    Time frame: Baseline

    Number of participants randomized per month of recruitment

  2. Study retention

    Time frame: Week 26

    Proportion of randomized participants who complete the 6 month assessment.

  3. Treatment engagement

    Time frame: Week 13

    Dose of treatment received (i.e., session attendance)

  4. Treatment Acceptability

    Time frame: Week 13

    Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction.

Secondary outcomes

  1. Cardiovascular Health

    Time frame: Week 13, Week 26

    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.

  2. Depressive symptoms

    Time frame: Week 13, Week 26

    Patient Health Questionnaire-9; Scores range from 0 to 27; higher scores indicate greater depressive symptoms.

  3. 7 Day Moderate to Vigorous Physical Activity

    Time frame: Week 13, Week 26

    Minutes spent in moderate to vigorous physical activity from 7 day Actigraph wear

  4. Self-Reported Moderate to Vigorous Physical Activity

    Time frame: Week 13, Week 26

    Minutes spent in moderate to vigorous physical activity over 7 days based on report from a 7 Day Physical Activity Recall interview

  5. Self-Reported Diet

    Time frame: Week 13, Week 26

    Mediterranean Eating Pattern for Americans Questionnaire; Scores range from 0-16 with higher scores indicating greater consistency with mediterranean style diet

  6. 7-day point prevalence abstinence from smoking

    Time frame: Week 13, Week 26

    Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed by carbon monoxide in a breath sample

  7. Sleep duration

    Time frame: Week 13, Week 26

    Average hours of sleep per night over 7 nights assessed via 7 day Actigraph wear

  8. Self-reported sleep duration

    Time frame: Week 13, Week 26

    Self-reported hours of sleep per night from the Pittsburgh Sleep Quality Index

  9. Body Mass Index

    Time frame: Week 13, Week 26

    Body weight (kilograms)/ Height (meters squared)

  10. Blood pressure

    Time frame: Week 13, Week 26

    Systolic and diastolic blood pressures (mmHg)

  11. Non-HDL cholesterol

    Time frame: Week 13, Week 26

    mg/dL; measured via point of care testing

  12. Hemoglobin A1C

    Time frame: Week 13, Week 26

    %; measured via point of care testing

  13. Medication adherence (cholesterol regimen)

    Time frame: Week 13, Week 26

    DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to cholesterol medication; scores range from 1-5.

  14. Medication adherence (blood pressure regimen)

    Time frame: Week 13, Week 26

    DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to blood pressure medication; scores range from 1-5

  15. Medication adherence (blood glucose regimen)

    Time frame: Week 13, Week 26

    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

  16. Major Adverse Cardiac Events

    Time frame: Week 26

    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

  17. All-cause mortality

    Time frame: Week 26

    Electronic medical record review

  18. Health Behavior Engagement Composite

    Time frame: Week 13, Week 26

    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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome

Acronym: HHH-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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