Healthy Heart Habits-2 (HHH-2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: Behavioral Activation for Health and Depression (BA-HD); Other: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare Research Institute
  • North Carolina
    • Greenville, North Carolina, United States, 27835
      • ECU Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care	Other: Enhanced Usual Care; Patients will receive depression and heart disease education, as well as a list of local mental health resources.
Experimental: Behavioral Activation for Health and Depression	Behavioral: Behavioral Activation for Health and Depression (BA-HD); BA-HD includes 8 - 10 sessions delivered over 10-12 weeks. Sessions use behavioral activation techniques to connect patient core values with goal-setting targeting activities that improve mood, alongside personalized adjustments to cardiovascular health behaviors (i.e., tobacco cessation, medication adherence, physical activity, diet, and sleep). Educational materials and commercially available tools like activity trackers, pillboxes, and portion control aids will accompany the goal-setting process to facilitate behavior change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Number of participants randomized per month of recruitment	Baseline
Study retention	Proportion of randomized participants who complete the 6 month assessment.	Week 26
Treatment engagement	Dose of treatment received (i.e., session attendance)	Week 13
Treatment Acceptability	Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction.	Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Health	Life's Essential 8 (LE8) Score; The LE8 classifies cardiovascular (CV) health across eight CV risk metrics: diet, physical activity, nicotine exposure, sleep health, weight, blood pressure, total cholesterol, and hemoglobin A1C. Each individual LE8 component is assigned a value ranging from 0 to 100. A total score is created by averaging each component score. Higher total scores reflect better overall CV health.	Week 13, Week 26
Depressive symptoms	Patient Health Questionnaire-9; Scores range from 0 to 27; higher scores indicate greater depressive symptoms.	Week 13, Week 26
7 Day Moderate to Vigorous Physical Activity	Minutes spent in moderate to vigorous physical activity from 7 day Actigraph wear	Week 13, Week 26
Self-Reported Moderate to Vigorous Physical Activity	Minutes spent in moderate to vigorous physical activity over 7 days based on report from a 7 Day Physical Activity Recall interview	Week 13, Week 26
Self-Reported Diet	Mediterranean Eating Pattern for Americans Questionnaire; Scores range from 0-16 with higher scores indicating greater consistency with mediterranean style diet	Week 13, Week 26
7-day point prevalence abstinence from smoking	Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed by carbon monoxide in a breath sample	Week 13, Week 26
Sleep duration	Average hours of sleep per night over 7 nights assessed via 7 day Actigraph wear	Week 13, Week 26
Self-reported sleep duration	Self-reported hours of sleep per night from the Pittsburgh Sleep Quality Index	Week 13, Week 26
Body Mass Index	Body weight (kilograms)/ Height (meters squared)	Week 13, Week 26
Blood pressure	Systolic and diastolic blood pressures (mmHg)	Week 13, Week 26
Non-HDL cholesterol	mg/dL; measured via point of care testing	Week 13, Week 26
Hemoglobin A1C	%; measured via point of care testing	Week 13, Week 26
Medication adherence (cholesterol regimen)	DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to cholesterol medication; scores range from 1-5.	Week 13, Week 26
Medication adherence (blood pressure regimen)	DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to blood pressure medication; scores range from 1-5	Week 13, Week 26
Medication adherence (blood glucose regimen)	DOSE-Nonadherence Extent of Nonadherence items will be used to assess self-reported medication adherence to both oral and injectable medication (assessed separately) to manage blood glucose; scores range from 1-5	Week 13, Week 26
Major Adverse Cardiac Events	Composite of hospitalization for unstable angina, urgent coronary revascularization, and non-fatal myocardial infarction determined via participant inquiry and confirmed through electronic medical record review	Week 26
All-cause mortality	Electronic medical record review	Week 26
Health Behavior Engagement Composite	A health behavior engagement composite score will be created that follows the LE8 scoring structure. LE8 component scores will be summed for physical activity, diet, combustible tobacco exposure, and sleep. Medication adherence will also be assigned a score ranging from 0 to 100 based on scaled DOSE-Nonadherence scores.	Week 13, Week 26

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Investigators: Principal Investigator: Emily Gathright, PhD, The Miriam Hospital; Principal Investigator: Andrew Busch, PhD, Hennepin Healthcare Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Population Characteristics; Health
• Other Study ID Numbers: R34HL165716-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No