Clinical trial NCT03122184: Positive Psychology for Acute Coronary Syndrome Patients
Official title: Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blinded, controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the PP-MI Based Health Behavior Intervention
timeFrame: 24 weeks
measure: Acceptability of the PP-MI Exercises: Utility Score
timeFrame: Weeks 1-12
measure: Acceptability of the PP-MI Exercises: Ease Score
timeFrame: Weeks 1-12
Secondary outcomes:
measure: Minutes of Moderate to Vigorous Physical Activity (Actigraph)
timeFrame: MVPA at 12 weeks and 24 weeks
measure: Change in Medication Adherence
timeFrame: Change in score from Baseline to 12 weeks, 24 weeks
measure: Change in Dietary Adherence
timeFrame: Change in score from Baseline to 12 weeks, 24 weeks
measure: Change in Positive Affect
timeFrame: Change in score from Baseline to 12 weeks, 24 weeks
measure: Change in Trait Optimism
timeFrame: Change in score from baseline to 12 week, 24 week
measure: Change in State Optimism
timeFrame: Change of score from Baseline to 12 weeks, 24 weeks
measure: Changes in HADS-A Scores
timeFrame: Change in score from Baseline to 12 week, 24 week
measure: Change in HADS-D Scores
timeFrame: Change in score from Baseline to 12 week, 24 week
measure: Change in Physical Function
timeFrame: Change of score from Baseline to 12 week, 24 week
measure: Change in SF-12 Scores (Physical)
timeFrame: Change of score from Baseline to 12 week, 24 week
measure: Change in SF-12 Scores (Mental)
timeFrame: Change of score from baseline to 12 and 24 weeks.
measure: Change in Adherence to Health Behaviors
timeFrame: Change of score from Baseline to 12 week, 24 week
measure: Change in Cardiac Symptoms
timeFrame: Change of score from Baseline to 12 week, 24 week
measure: Change in Physical Activity
timeFrame: Change of score from Baseline to 12 week, 24 week
measure: Change in Perceived Stress
timeFrame: Change of score from Baseline to 12 week, 24 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References: