Acute Coronary SyndromeHHH-2NCT06440278
Healthy Heart Habits-2
A study testing Behavioral Activation for Health and Depression (BA-HD) in people with Acute Coronary Syndrome, run by The Miriam Hospital at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Behavioral Activation for Health and Depression (BA-HD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2024to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ECU Health
Greenville, North Carolina, 27835
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
The Miriam Hospital
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Behavioral Activation for Health and Depression (BA-HD), Enhanced Usual Care
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation for Health and Depression (BA-HD)Behavioural
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.
Enhanced Usual CareOther
Patients will receive depression and heart disease education, as well as a list of local mental health resources.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation for Health and Depression | Experimental | Not described Receives: Behavioral: Behavioral Activation for Health and Depression (BA-HD) |
| Enhanced Usual Care | Active comparator | Not described Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Number of participants randomized per month of recruitment
Measured: Baseline
Study retention
Proportion of randomized participants who complete the 6 month assessment.
Measured: Week 26
Treatment engagement
Dose of treatment received (i.e., session attendance)
Measured: Week 13
Treatment Acceptability
Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction.
Measured: Week 13
Secondary outcomes (18)
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.
Measured: Week 13, Week 26
Depressive symptoms
Patient Health Questionnaire-9; Scores range from 0 to 27; higher scores indicate greater depressive symptoms.
Measured: Week 13, Week 26
7 Day Moderate to Vigorous Physical Activity
Minutes spent in moderate to vigorous physical activity from 7 day Actigraph wear
Measured: 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
Measured: 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
Measured: 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
Measured: Week 13, Week 26
Sleep duration
Average hours of sleep per night over 7 nights assessed via 7 day Actigraph wear
Measured: Week 13, Week 26
Self-reported sleep duration
Self-reported hours of sleep per night from the Pittsburgh Sleep Quality Index
Measured: Week 13, Week 26
Body Mass Index
Body weight (kilograms)/ Height (meters squared)
Measured: Week 13, Week 26
Blood pressure
Systolic and diastolic blood pressures (mmHg)
Measured: Week 13, Week 26
Non-HDL cholesterol
mg/dL; measured via point of care testing
Measured: Week 13, Week 26
Hemoglobin A1C
%; measured via point of care testing
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Week 26
All-cause mortality
Electronic medical record review
Measured: 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.
Measured: Week 13, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start13 Jun 2024
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily C. Gathright, PhD, The Miriam Hospital
- Investigators
- Emily Gathright, PhD, Principal investigator, The Miriam HospitalAndrew Busch, PhD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440278
- Sponsor's protocol ID
- R34HL165716-01A1
- Acronym
- HHH-2
- Status last verified
- Jul 2026
- First submitted
- 28 May 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06440278
- Acronym / sponsor ID
- HHH-2 / R34HL165716-01A1
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- English-language fluency
- Resides within 90 minutes (driving time) of each site with no plans to relocate beyond that range during study participation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Behavioral Activation for Health and Depression |
| Enhanced Usual CarePatients will receive depression and heart disease education, as well as a list of local mental health resources. | Other | Enhanced Usual Care |
Primary outcome
Recruitment feasibility
Time frame: Baseline
Number of participants randomized per month of recruitment
Study retention
Time frame: Week 26
Proportion of randomized participants who complete the 6 month assessment.
Treatment engagement
Time frame: Week 13
Dose of treatment received (i.e., session attendance)
Treatment Acceptability
Time frame: Week 13
Client Satisfaction Questionnaire-8; Scores range from 8-32 with higher scores indicating greater treatment satisfaction.
18 secondary outcomes
Cardiovascular Health
Time frame: Week 13, Week 26
Depressive symptoms
Time frame: Week 13, Week 26
7 Day Moderate to Vigorous Physical Activity
Time frame: Week 13, Week 26
Self-Reported Moderate to Vigorous Physical Activity
Time frame: Week 13, Week 26
Self-Reported Diet
Time frame: Week 13, Week 26
7-day point prevalence abstinence from smoking
Time frame: Week 13, Week 26
Sleep duration
Time frame: Week 13, Week 26
Self-reported sleep duration
Time frame: Week 13, Week 26
Body Mass Index
Time frame: Week 13, Week 26
Blood pressure
Time frame: Week 13, Week 26
Non-HDL cholesterol
Time frame: Week 13, Week 26
Hemoglobin A1C
Time frame: Week 13, Week 26
Medication adherence (cholesterol regimen)
Time frame: Week 13, Week 26
Medication adherence (blood pressure regimen)
Time frame: Week 13, Week 26
Medication adherence (blood glucose regimen)
Time frame: Week 13, Week 26
Major Adverse Cardiac Events
Time frame: Week 26
All-cause mortality
Time frame: Week 26
Health Behavior Engagement Composite
Time frame: Week 13, Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Gathright, PhD principal investigator
The Miriam Hospital
Andrew Busch, PhD principal investigator
Hennepin Healthcare Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation for Health and Depression (BA-HD) in people with Acute Coronary Syndrome, run by The Miriam Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.