NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: The Miriam Hospital
Conditions: Acute Coronary Syndrome
Interventions: Behavioral Activation for Health and Depression (BA-HD), Enhanced Usual Care
Countries: United States
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.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Minneapolis, Minnesota, United States
- Greenville, North Carolina, United States
- Providence, Rhode Island, United States