Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05412862

Conditions

Acute Coronary Syndrome

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Positive Psychology + Motivational Interviewing

Study Details

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.

Conditions

Acute Coronary Syndrome

Physical Inactivity

Study ID

NCT05412862

Start date

Sep 12, 2022

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positive Psychology + Motivational Interviewing

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).

no intervention: Treatment as Usual

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.

Interventions

Positive Psychology + Motivational Interviewing

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.

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 ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Positive psychology
  • Physical Activity
  • Motivational Interviewing
  • Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-20.