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Positive Psychology + Motivational Interviewing for Acute Coronary Syndrome (PEACE-V Trial)
N/A
Recruiting
Led By Jeff C Huffman, M.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ACS (myocardial infarction or unstable angina)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2.7 years
Awards & highlights
PEACE-V Trial Summary
This trial tests a 12-week positive-psychology intervention to see if it can improve physical activity in post-ACS patients compared to usual care.
Who is the study for?
This trial is for people who've had a recent heart event (like a heart attack or unstable angina) and don't exercise much—less than 150 minutes of moderate activity per week. They must be able to read, write, and speak English, receive texts, and be physically able to work out unless another health issue prevents it.Check my eligibility
What is being tested?
The study tests if a program combining positive psychology with motivational interviewing can help patients after an acute coronary syndrome. It's delivered remotely over 12 weeks with supportive texts for another 12 weeks compared to the usual care post-heart event.See study design
What are the potential side effects?
Since this intervention involves psychological support and encouragement for physical activity rather than medication, side effects may include discomfort from increased activity levels or emotional distress but are generally expected to be minimal.
PEACE-V Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a heart attack or unstable angina.
PEACE-V Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2.7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2.7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
Secondary outcome measures
Change in Light Intensity Activity
Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
Other outcome measures
All-cause hospitalizations
Attendance at cardiac rehabilitation
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks
+24 morePEACE-V Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Psychology + Motivational InterviewingExperimental Treatment1 Intervention
Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).
Group II: Treatment as UsualActive Control1 Intervention
Participants in the treatment as usual (TAU) arm will not receive any specific intervention, though they will be free to receive any post-ACS treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positive Psychology + Motivational Interviewing
2017
N/A
~200
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,165 Total Patients Enrolled
19 Trials studying Acute Coronary Syndrome
4,431 Patients Enrolled for Acute Coronary Syndrome
Jeff C Huffman, M.D.Principal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do less than 150 minutes of moderate to vigorous physical activity each week, as confirmed by a special device called an accelerometer.I cannot read, write, or speak in English.I cannot be physically active due to a condition like arthritis.You have a medical condition that is likely to cause death within the next 6 months.You have trouble with thinking and remembering things, as assessed by a short test.I have had a heart attack or unstable angina.You have a score of 15 or higher on the Patient Health Questionnaire-9, which measures moderate to severe depression.You are currently involved in another program meant to improve health or physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual
- Group 2: Positive Psychology + Motivational Interviewing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do participants aged sixty and above qualify for inclusion in this clinical research?
"This trial is seeking participants who are 18 or more years old, and under the age of 75."
Answered by AI
Are there still spots available to join this experiment?
"Unfortunately, the clinical trial hosted on clinicialtrials.gov is not currently recruiting participants. Initially posted September 1st 2022 and last updated 9th of that same month, this study has yet to resume enrolment; however, there are other similar studies with open recruitment slots numbering at 1509 available now."
Answered by AI
What sort of individuals would be appropriate candidates to join this medical study?
"To participate in this medical trial, individuals should have acute coronary syndrome and be between 18-75 years of age. It is believed that around 280 patients will enroll."
Answered by AI
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