Positive Psychology for Acute Coronary Syndrome Patients

NCT ID: NCT03122184

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-11-26

Brief Summary

This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes. The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.

Detailed Description

The initial study visit will occur in-person two weeks after discharge from the hospital. Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health. Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions. A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise. If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise. Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise. Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant. Participants in both groups will then complete twelve 30-minute 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. Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures. Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.

Conditions

ACS - Acute Coronary Syndrome

Study Design

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

Study Groups

Positive Psychology + Motivational Interviewing

Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.

Group Type: EXPERIMENTAL

Positive Psychology + Motivational Interviewing

Intervention Type: BEHAVIORAL

For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.

Motivational Interviewing Health Education

Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.

Group Type: ACTIVE_COMPARATOR

Motivational Interviewing Health Education

Intervention Type: BEHAVIORAL

Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).

Interventions

Positive Psychology + Motivational Interviewing

For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.

Intervention Type: BEHAVIORAL

Motivational Interviewing Health Education

Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units
• Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
• Age 18 or older
• Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6

Exclusion Criteria

• Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
• Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
• Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
• Inability to communicate in English.
• Inability to participate in physical activity

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Associate Chief of Psychiatry for Clinical Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff Huffman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

R01HL113272

Identifier Type: NIH

Identifier Source: org_study_id

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