Positive Psychology for Acute Coronary Syndrome Patients



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/16/2018
Start Date:May 1, 2017
End Date:November 26, 2018

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Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial

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.

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.

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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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