Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)

• ClinicalTrials.gov Identifier: NCT03122184
• Recruitment Status: Completed
• First Posted: April 20, 2017
• Results First Posted: November 13, 2019
• Last Update Posted: May 14, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Jeff C. Huffman, MD, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
ACS - Acute Coronary Syndrome	Behavioral: Positive Psychology + Motivational Interviewing; Behavioral: Motivational Interviewing Health Education	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, single-blinded, controlled trial
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: July 10, 2018
• Actual Study Completion Date: November 26, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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).

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the PP-MI Based Health Behavior Intervention [ Time Frame: 24 weeks ]
   Feasibility will be measured by examining the number of completed exercises.
2. Acceptability of the PP-MI Exercises: Utility Score [ Time Frame: Weeks 1-12 ]
   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.
3. Acceptability of the PP-MI Exercises: Ease Score [ Time Frame: Weeks 1-12 ]
   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.

Secondary Outcome Measures :

1. Minutes of Moderate to Vigorous Physical Activity (Actigraph) [ Time Frame: MVPA at 12 weeks and 24 weeks ]
   ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
2. Change in Medication Adherence [ Time Frame: Change in score from Baseline to 12 weeks, 24 weeks ]
   Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence.
3. Change in Dietary Adherence [ Time Frame: Change in score from Baseline to 12 weeks, 24 weeks ]
   Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence.
4. Change in Positive Affect [ Time Frame: Change in score from Baseline to 12 weeks, 24 weeks ]
   The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.
5. Change in Trait Optimism [ Time Frame: Change in score from baseline to 12 week, 24 week ]
   Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism.
6. Change in State Optimism [ Time Frame: Change of score from Baseline to 12 weeks, 24 weeks ]
   Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
7. Changes in HADS-A Scores [ Time Frame: Change in score from Baseline to 12 week, 24 week ]
   The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety.
8. Change in HADS-D Scores [ Time Frame: Change in score from Baseline to 12 week, 24 week ]
   The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).
9. Change in Physical Function [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
   Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity.
10. Change in SF-12 Scores (Physical) [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
    The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
11. Change in SF-12 Scores (Mental) [ Time Frame: Change of score from baseline to 12 and 24 weeks. ]
    The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
12. Change in Adherence to Health Behaviors [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
    Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors.
13. Change in Cardiac Symptoms [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
    Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms.
14. Change in Physical Activity [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
    Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
15. Change in Perceived Stress [ Time Frame: Change of score from Baseline to 12 week, 24 week ]
    Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Jeff Huffman, MD; Massachusetts General Hospital

  Study Documents (Full-Text)

Documents provided by Jeff C. Huffman, MD, Massachusetts General Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2018

More Information

• Responsible Party: Jeff C. Huffman, MD, Associate Chief of Psychiatry for Clinical Services, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03122184
• Other Study ID Numbers: R01HL113272 ( U.S. NIH Grant/Contract )
• First Posted: April 20, 2017
• Results First Posted: November 13, 2019
• Last Update Posted: May 14, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acute Coronary Syndrome; Syndrome; Disease; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases