Healthy Heart Habits-2

NCT06440278 | Active Not Recruiting DMC

• 1 other identifier: R34HL165716-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (18)

• Cardiovascular Health

  Week 13, Week 26

• Depressive symptoms

  Week 13, Week 26

• 7 Day Moderate to Vigorous Physical Activity

  Week 13, Week 26

• Self-Reported Moderate to Vigorous Physical Activity

  Week 13, Week 26

• Self-Reported Diet

  Week 13, Week 26

Study Arms (2)

Behavioral Activation for Health and Depression

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

Other: Enhanced Usual Care

Interventions

Enhanced Usual Care OTHER

Patients will receive depression and heart disease education, as well as a list of local mental health resources.

Enhanced Usual Care

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

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.

Behavioral Activation for Health and Depression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (3)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

ECU Health

Greenville, North Carolina, 27835, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Health

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Emily Gathright, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• Andrew Busch, PhD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: June 13, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (3)