Positive Emotions Following Acute Cardiac Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorMassachusetts General Hospital
About this trial
The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ACS (myocardial infarction or unstable angina)
Suboptimal physical activity (score of < 6 on the Medical Outcomes study Specific Adherence Scale item related to physical activity)
Disqualifiers
Cognitive deficits (assessed via a 6-item cognitive screening tool)
Medical conditions likely to lead to death within 6 months.
Moderate-severe depression (Patient Health Questionnaire-9 [PHQ-9] score ≥15)
Inability to participate in physical activity due to another medical condition (e.g., arthritis)
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Psychology + Motivational Interviewing
BehavioralThe 12-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in physical activity.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Positive Psychology + Motivational InterviewingExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
Time frame
Measured for 7 days at baseline and 24 weeksSecondary outcomes
1
Change in Light Intensity Activity
Light intensity activity will be measured via an accelerometer and recorded in mean minutes/day.
Time frame
Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks2
Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
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 HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Time frame
Baseline, 12 weeks, 24 weeks, 48 weeksOther outcomes
1
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
Time frame
Measured for 7 days at baseline, 12 weeks, and 48 weeks2
Change in Sedentary time
Sedentary time will be measured via an accelerometer and recorded in mean minutes/day.
Time frame
Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks3
Change in optimism (Life Orientation Test - Revised [LOT-R])
Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.
Time frame
Baseline, 12 weeks, 24 weeks, 48 weeks4
Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-27). Higher scores indicate higher levels of depression.
Time frame
Baseline, 12 weeks, 24 weeks, 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov