N/A
N=47
Positive Psychology for Acute Coronary Syndrome Patients
ACS - Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03122184 ↗Enrolled (actual)
47
Serious AEs
46.8%
Results posted
Nov 2019
Primary outcome: Primary: Feasibility of the PP-MI Based Health Behavior Intervention — 10.0 exercises completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Psychology + Motivational Interviewing (Behavioral); Motivational Interviewing Health Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the PP-MI Based Health Behavior Intervention |
10.0 | — |
| PRIMARY Acceptability of the PP-MI Exercises: Utility Score |
8.0; 8.2 | — |
| PRIMARY Acceptability of the PP-MI Exercises: Ease Score |
8.3; 8.1 | — |
| SECONDARY Minutes of Moderate to Vigorous Physical Activity (Actigraph) |
33.0; 23.2; 34.6; 18.1 | — |
| SECONDARY Change in Medication Adherence |
5; 5; 0; -6 | — |
| SECONDARY Change in Dietary Adherence |
-2.8; -17.6; 2.1; -7.7 | — |
| SECONDARY Change in Positive Affect |
8.8; 4.9; 9.5; 2.2 | — |
| SECONDARY Change in Trait Optimism |
2.2; 2.0; 1.7; 2.8 | — |
| SECONDARY Change in State Optimism |
5.3; -.1; 6.0; .6 | — |
| SECONDARY Changes in HADS-A Scores |
-2.8; -1.3; -2.3; -1.9 | — |
| SECONDARY Change in HADS-D Scores |
-1.8; .5; -1.5; -0.8 | — |
| SECONDARY Change in Physical Function |
9.7; 4.4; 14.1; 4.9 | — |
| SECONDARY Change in SF-12 Scores (Physical) |
8.0; 7.2; 12.3; 6.8 | — |
| SECONDARY Change in SF-12 Scores (Mental) |
8.8; 1.3; 6.3; 2.6 | — |
| SECONDARY Change in Adherence to Health Behaviors |
4.9; 3.5; 4.4; 3.3 | — |
| SECONDARY Change in Cardiac Symptoms |
-6.6; -4.8; -6.6; -5.1 | — |
| SECONDARY Change in Physical Activity |
649.5; 159.9; -359.4; -171.1 | — |
| SECONDARY Change in Perceived Stress |
-2.8; -1.4; -2.3; -2.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03122184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.