Acute Coronary SyndromePEACE-VNCT05412862
Positive Emotions Following Acute Cardiac Events
A study testing Positive Psychology + Motivational Interviewing in people with Acute Coronary Syndrome and Physical Inactivity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Coronary Syndrome, Physical Inactivity
- What is being tested?
- Positive Psychology + Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jeff Huffman, M.D., 617-724-2910, jhuffman@mgh.harvard.edu
About this study
Official title: A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
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.
Read the detailed description
The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks) in post-ACS patients. The investigators will enroll 280 post-ACS patients, who will take part in either a 12-week intervention (with 24 weeks of supplemental text messages), or receive post-ACS treatment as usual.
In this project, the investigators hope to do the following:
- Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with ACS on physical activity-related outcomes, as compared to the treatment as usual group.
- Assess the intervention's impact on psychological (e.g. positive affect), functional (e.g. physical function), and behavioral (e.g. overall adherence) outcomes.
- Explore the intervention's impact on markers of cardiovascular health (e.g., cardiac biomarkers), as well as major adverse cardiac events/readmissions.
Participants will be screened and enrolled during admission for an ACS. They will be provided with a accelerometer to monitor their physical activity for one week prior to their first in-person visit. At their first visit, they will answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and provide a fasting blood sample. Upon confirmation of adequate physical activity, participants will be randomized to receive the PP-MI intervention or treatment as usual.
Participants in the intervention will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.
Following the first in-person visit, participants in the treatment condition will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Participants in the treatment condition will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). These messages will focus on the PP activity and physical activity. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity.
At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations. They will also provide a fasting blood sample.
Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.
- Conditions
- Acute Coronary Syndrome, Physical Inactivity
- Being tested
- Positive Psychology + Motivational Interviewing
- Keywords
- Positive psychology, Physical Activity, Motivational Interviewing, Adherence
- Medical subject headings
- Acute Coronary Syndrome, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology + Motivational InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | 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). Receives: Behavioral: Positive Psychology + Motivational Interviewing |
| Treatment as Usual | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured for 7 days at baseline and 24 weeks
Secondary outcomes (2)
Change in Light Intensity Activity
Light intensity activity will be measured via an accelerometer and recorded in mean minutes/day.
Measured: 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)
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Measured: Baseline, 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start12 Sep 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Randomized, single-blinded, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412862
- Sponsor's protocol ID
- 2021P003302
- Acronym
- PEACE-V
- Status last verified
- Apr 2026
- First submitted
- 25 May 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05412862
- Acronym / sponsor ID
- PEACE-V / 2021P003302
- Conditions
- Acute Coronary Syndrome, Physical Inactivity
- Keywords
- Positive psychology, Physical Activity, Motivational Interviewing, Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Jun 2022 (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.
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.
Detailed description
The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks) in post-ACS patients. The investigators will enroll 280 post-ACS patients, who will take part in either a 12-week intervention (with 24 weeks of supplemental text messages), or receive post-ACS treatment as usual.
In this project, the investigators hope to do the following:
- Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with ACS on physical activity-related outcomes, as compared to the treatment as usual group.
- Assess the intervention's impact on psychological (e.g. positive affect), functional (e.g. physical function), and behavioral (e.g. overall adherence) outcomes.
- Explore the intervention's impact on markers of cardiovascular health (e.g., cardiac biomarkers), as well as major adverse cardiac events/readmissions.
Participants will be screened and enrolled during admission for an ACS. They will be provided with a accelerometer to monitor their physical activity for one week prior to their first in-person visit. At their first visit, they will answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and provide a fasting blood sample. Upon confirmation of adequate physical activity, participants will be randomized to receive the PP-MI intervention or treatment as usual.
Participants in the intervention will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.
Following the first in-person visit, participants in the treatment condition will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Participants in the treatment condition will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). These messages will focus on the PP activity and physical activity. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity.
At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations. They will also provide a fasting blood sample.
Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blinded, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | Behavioral: Positive Psychology + Motivational InterviewingEach 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 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Positive Psychology + Motivational InterviewingThe 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. | Behavioural | Positive Psychology + Motivational Interviewing |
Primary outcome
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
Time frame: Measured for 7 days at baseline and 24 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
2 secondary outcomes
Change in Light Intensity Activity
Time frame: 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)
Time frame: Baseline, 12 weeks, 24 weeks, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Jeff C Huffman, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology + Motivational Interviewing in people with Acute Coronary Syndrome and Physical Inactivity, run by Massachusetts General Hospital at 1 site 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff C Huffman, M.D. (617-724-2910, jhuffman@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks (time frame: Measured for 7 days at baseline and 24 weeks). 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 20 Apr 2026.