NCT06440278Completed
Healthy Heart Habits-2
Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 28 May 2024
- Start date
- 13 Jun 2024
- Primary completion date
- 7 Jul 2026
- Lead sponsor
- The Miriam Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06440278
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 13 Jun 2024 to the primary completion date, 7 Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chart indication of significant cognitive impairment (e.g., chart-documented dementia), Current exacerbation of serious mental illness,
- Hearing impairment that prevents telephone/video communication for intervention and assessment purposes,
- Current engagement in cardiac rehabilitation or other regular counseling treatment targeting depression or health behavior change
Other
- Suicidality,
- Current hospice care, and
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ECU Health Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hennepin Healthcare Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| The Miriam Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.