Positive Emotions Following Acute Cardiac Events

NCT ID: NCT05412862

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2027-06-30

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.

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:

1. 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.

2. Assess the intervention's impact on psychological (e.g. positive affect), functional (e.g. physical function), and behavioral (e.g. overall adherence) outcomes.

3. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Positive Psychology + Motivational Interviewing

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Director, Cardiac Psychiatry Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff C Huffman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeff C Huffman, M.D.

Role: CONTACT

jhuffman@partners.org

617-724-2910

Facility Contacts

Jeff Huffman, M.D.

Role: primary

jhuffman@mgh.harvard.edu

617-724-2910

Other Identifiers

2021P003302

Identifier Type: -

Identifier Source: org_study_id