Positive Emotions Following Acute Cardiac Events

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05412862
Status
Recruiting
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Conditions

  • Acute Coronary Syndrome
  • Physical Inactivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Positive Psychology + Motivational Interviewing — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Sep 12, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jeff Huffman, M.D.
[email protected]
617-724-2910

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By research site
Massachusetts General Hospital· Boston, MA

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