Positive Emotions Following Acute Cardiac Events
PEACE-V
A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
1 other identifier
interventional
280
1 country
1
Brief Summary
The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 20, 2026
April 1, 2026
5.6 years
May 25, 2022
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
Measured for 7 days at baseline and 24 weeks
Secondary Outcomes (2)
Change in Light Intensity Activity
Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
Baseline, 12 weeks, 24 weeks, 48 weeks
Other Outcomes (27)
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks
Measured for 7 days at baseline, 12 weeks, and 48 weeks
Change in Sedentary time
Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Change in optimism (Life Orientation Test - Revised [LOT-R])
Baseline, 12 weeks, 24 weeks, 48 weeks
- +24 more other outcomes
Study Arms (2)
Positive Psychology + Motivational Interviewing
EXPERIMENTALEach 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).
Treatment as Usual
NO INTERVENTIONParticipants in the treatment as usual (TAU) arm will not receive any specific intervention, though they will be free to receive any post-ACS treatment.
Interventions
The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in physical activity.
Eligibility Criteria
You may qualify if:
- ACS (myocardial infarction or unstable angina)
- Suboptimal physical activity (score of \< 6 on the Medical Outcomes study Specific Adherence Scale item related to physical activity)
You may not qualify if:
- Cognitive deficits (assessed via a 6-item cognitive screening tool)
- Medical conditions likely to lead to death within 6 months.
- Moderate-severe depression (Patient Health Questionnaire-9 \[PHQ-9\] score ≥15)
- Inability to participate in physical activity due to another medical condition (e.g., arthritis)
- Inability to read, write, or speak in English
- Inability to receive text-messages
- Current participation in another intervention or program that has been designed to promote well-being or physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff C Huffman, M.D.
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Cardiac Psychiatry Research Program
Study Record Dates
First Submitted
May 25, 2022
First Posted
June 9, 2022
Study Start
September 12, 2022
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- This information will be shared prior to the end of the study funding period.
- Access Criteria
- Investigators who are interested in obtaining access to this information will be asked to submit a request to the principal investigator outlining the proposed use of the data and would need to agree to certain conditions (e.g., not attempting to identify individual participants, destroying data once the use of the data is complete) prior to obtaining access.
To promote sharing of study data with other researchers, we will create a deidentified study dataset. We will include both item-level and summary scores for each scale and will include data from the baseline, 12-week, 24-week, and 48-week time points.