Coaching program for improving health behaviors in adults after heart issues

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

This study is testing a coaching program to help adults who recently had heart issues and are feeling down to improve their health habits compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Miriam Hospital (other)
• Locations: 3 sites (Minneapolis, Minnesota and 2 other locations)
• Trial ID: NCT06440278 on ClinicalTrials.gov

What this trial studies

This study involves sixty adults who have experienced acute coronary syndrome (ACS) within the past 2-12 months. Participants will be randomized into two groups: one receiving a coaching program aimed at addressing depressed mood and promoting health behavior changes, and the other receiving enhanced usual care. The study aims to evaluate the feasibility and acceptability of the coaching program, known as Behavioral Activation for Health and Depression (BA-HD), while also establishing consistent protocols across three different sites in preparation for a larger efficacy trial. The focus is on improving health behaviors that are often neglected post-ACS, particularly in individuals experiencing depression.

Who should consider this trial

Good fit: Ideal candidates are adults who have had a documented acute coronary syndrome event within the last 2-12 months and are experiencing depressed mood.

Not a fit: Patients with significant cognitive impairment, current serious mental illness exacerbations, or those who are suicidal may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance health behaviors and reduce the risk of recurrent acute coronary syndrome in patients.

How similar studies have performed: While the specific approach of BA-HD may be novel, similar interventions targeting depression and health behavior change have shown promise in other studies.

Eligibility criteria

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:

  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:

* 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

Where this trial is running

Minneapolis, Minnesota and 2 other locations

• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (RECRUITING)
• ECU Health — Greenville, North Carolina, United States (RECRUITING)
• The Miriam Hospital — Providence, Rhode Island, United States (RECRUITING)

Study contacts

• Principal investigator: Emily Gathright, PhD — The Miriam Hospital
• Study coordinator: Emily Gathright, PhD

Conditions: Acute Coronary Syndrome