Positive Psychology for Acute Coronary Syndrome Patients

NCT03122184 | Completed Results DMC

• 1 other identifier: R01HL113272
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

ACS - Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (3)

• Feasibility of the PP-MI Based Health Behavior Intervention

  Feasibility will be measured by examining the number of completed exercises.

  24 weeks

• Acceptability of the PP-MI Exercises: Utility Score

  Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.

  Weeks 1-12

• Acceptability of the PP-MI Exercises: Ease Score

  Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.

  Weeks 1-12

Secondary Outcomes (15)

• Minutes of Moderate to Vigorous Physical Activity (Actigraph)

  MVPA at 12 weeks and 24 weeks

• Change in Medication Adherence

  Change in score from Baseline to 12 weeks, 24 weeks

• Change in Dietary Adherence

  Change in score from Baseline to 12 weeks, 24 weeks

• Change in Positive Affect

  Change in score from Baseline to 12 weeks, 24 weeks

• Change in Trait Optimism

  Change in score from baseline to 12 week, 24 week

Study Arms (2)

Positive Psychology + Motivational Interviewing

EXPERIMENTAL

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.

Behavioral: Positive Psychology + Motivational Interviewing

Motivational Interviewing Health Education

ACTIVE COMPARATOR

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.

Behavioral: Motivational Interviewing Health Education

Interventions

Positive Psychology + Motivational Interviewing 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.

Positive Psychology + Motivational Interviewing

Motivational Interviewing Health Education 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).

Motivational Interviewing Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Psychology, Positive; Motivational Interviewing

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jeff Huffman
• Organization: Massachusetts General Hospital

JHUFFMAN@mgh.harvard.edu

617-724-2910

Study Officials

• Jeff Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating study staff will be aware of the patient's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Psychiatry for Clinical Services

Model Details: Randomized, single-blinded, controlled trial

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: July 10, 2018
• Study Completion: November 26, 2018
• Last Updated: May 14, 2020
• Results First Posted: November 13, 2019

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)