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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.Check my eligibility
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.See study design
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~week 13, week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 13, week 26 for reporting.

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 more
Secondary outcome measures
7 Day Moderate to Vigorous Physical Activity
7-day point prevalence abstinence from smoking
All-cause mortality
+15 more

Trial 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
241 Previous Clinical Trials
37,528 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
~40 spots leftby Apr 2025