Healthy Heart Habits-2 (HHH-2)

Lifespan

Status

Enrolling

Conditions

Acute Coronary Syndrome

Treatments

Other: Enhanced Usual Care

Behavioral: Behavioral Activation for Health and Depression (BA-HD)

Study type

Interventional

Funder types

Other

Identifiers

NCT06440278

R34HL165716-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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