Clinical trial NCT06440278: Healthy Heart Habits-2
Official title: Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Recruitment feasibility
timeFrame: Baseline
measure: Study retention
timeFrame: Week 26
measure: Treatment engagement
timeFrame: Week 13
measure: Treatment Acceptability
timeFrame: Week 13
Secondary outcomes:
measure: Cardiovascular Health
timeFrame: Week 13, Week 26
measure: Depressive symptoms
timeFrame: Week 13, Week 26
measure: 7 Day Moderate to Vigorous Physical Activity
timeFrame: Week 13, Week 26
measure: Self-Reported Moderate to Vigorous Physical Activity
timeFrame: Week 13, Week 26
measure: Self-Reported Diet
timeFrame: Week 13, Week 26
measure: 7-day point prevalence abstinence from smoking
timeFrame: Week 13, Week 26
measure: Sleep duration
timeFrame: Week 13, Week 26
measure: Self-reported sleep duration
timeFrame: Week 13, Week 26
measure: Body Mass Index
timeFrame: Week 13, Week 26
measure: Blood pressure
timeFrame: Week 13, Week 26
measure: Non-HDL cholesterol
timeFrame: Week 13, Week 26
measure: Hemoglobin A1C
timeFrame: Week 13, Week 26
measure: Medication adherence (cholesterol regimen)
timeFrame: Week 13, Week 26
measure: Medication adherence (blood pressure regimen)
timeFrame: Week 13, Week 26
measure: Medication adherence (blood glucose regimen)
timeFrame: Week 13, Week 26
measure: Major Adverse Cardiac Events
timeFrame: Week 26
measure: All-cause mortality
timeFrame: Week 26
measure: Health Behavior Engagement Composite
timeFrame: Week 13, Week 26
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
city: Greenville
country: United States
facility: ECU Health
state: North Carolina
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Emily Gathright, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin Healthcare Research Institute
name: Andrew Busch, PhD
role: PRINCIPAL_INVESTIGATOR
References: