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Behavioural Intervention
Behavioral Coaching for Heart Attack (HHH-2 Trial)
N/A
Recruiting
Led By Emily Gathright, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-ACS depressed mood defined as a PHQ-9 score ≥ 10 upon screening
Be older than 18 years old
Must not have
Current hospice care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 13, week 26
Awards & highlights
Summary
This trial will involve sixty adults who recently had a heart attack in three different states. They will be divided into two groups: one group will receive a coaching program for improving mood and health behaviors, while
Who is the study for?
This trial is for adults who've had an acute coronary syndrome event in the last 2-12 months. It's available in Rhode Island, North Carolina, and Minnesota. Participants should be willing to undergo a coaching program or receive enhanced usual care.
What is being tested?
The study compares two approaches: Behavioral Activation for Health and Depression (BA-HD), which involves coaching for mood and health behavior changes, versus Enhanced Usual Care. The goal is to prepare for a larger future trial by testing these methods' practicality.
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medication, side effects are minimal but may include discomfort from discussing personal issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been feeling very down or depressed lately.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving hospice care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment feasibility
Study retention
Treatment Acceptability
+1 moreSecondary outcome measures
7 Day Moderate to Vigorous Physical Activity
7-day point prevalence abstinence from smoking
All-cause mortality
+15 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation for Health and DepressionExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The Miriam HospitalLead Sponsor
243 Previous Clinical Trials
37,647 Total Patients Enrolled
4 Trials studying Acute Coronary Syndrome
321 Patients Enrolled for Acute Coronary Syndrome
Emily Gathright, PhDPrincipal InvestigatorThe Miriam Hospital
Andrew Busch, PhDPrincipal InvestigatorHennepin Healthcare Research Institute
1 Previous Clinical Trials
233 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
233 Patients Enrolled for Acute Coronary Syndrome
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