Positive Psychology + Motivational Interviewing for Acute Coronary Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Acute Coronary Syndrome+2 More
Positive Psychology + Motivational Interviewing - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions

  • Acute Coronary Syndrome
  • Physical Inactivity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 2.7 years

Week 48
Attendance at cardiac rehabilitation
Week 48
Change in Fat/saturated fat/cholesterol intake (Meat, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks [MEDFICTS])
Change in adherence to cardiac medications
Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
Change in blood pressure (millimeters of mercury)
Change in body mass index (kilograms per square meter)
Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])
Change in endothelin-1 (picograms per milliliter)
Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])
Change in glucose (milligrams per deciliter)
Change in high sensitivity C-reactive protein (milligrams per liter)
Change in interleukin-6 (picograms per milliliter)
Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])
Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)
Change in mental health-related quality of life(Medical Outcomes Study Short Form-12 [SF-12] mental component score)
Change in optimism (Life Orientation Test - Revised [LOT-R])
Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])
Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])
Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)
Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])
Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])
Change in triglycerides (milligrams per deciliter)
Change in weight (kilograms)
Week 24
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
Week 48
Change in Light Intensity Activity
Change in Sedentary time
Week 48
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks
Year 7
All-cause hospitalizations
Major adverse cardiac events (MACE)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment as Usual
1 of 2
Positive Psychology + Motivational Interviewing
1 of 2
Active Control
Experimental Treatment

280 Total Participants · 2 Treatment Groups

Primary Treatment: Positive Psychology + Motivational Interviewing · No Placebo Group · N/A

Positive Psychology + Motivational Interviewing
Behavioral
Experimental Group · 1 Intervention: Positive Psychology + Motivational Interviewing · Intervention Types: Behavioral
Treatment as UsualNoIntervention Group · 1 Intervention: Treatment as Usual · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positive Psychology + Motivational Interviewing
2017
N/A
~200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2.7 years
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital 1Photo of Massachusetts General Hospital 2Photo of Massachusetts General Hospital 3
1993First Recorded Clinical Trial
20 TrialsResearching Acute Coronary Syndrome
2430 CompletedClinical Trials

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,517 Total Patients Enrolled
19 Trials studying Acute Coronary Syndrome
4,430 Patients Enrolled for Acute Coronary Syndrome
Jeff C Huffman, M.D.Principal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
3 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.