Positive Emotions After Acute Coronary Events at Northwestern University (PEACE-NU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04062383|
Recruitment Status : Suspended (In-person recruitment suspended due to COVID)
First Posted : August 20, 2019
Last Update Posted : August 12, 2021
This study is a single-arm, 12-week trial to test the feasibility of a PP-MI intervention for patients recently admitted following ACS. PP-MI is a novel positive psychology-based health behavior intervention that is adapted for patients hospitalized for ACS. The intervention aims to cultivate positive emotions in this vulnerable population that could provide broad and significant health benefits, and may have distinct-and more powerful-effects than simply attempting to dampen negative emotions.
The primary aim is to assess whether the intervention exercises are feasible and linked with immediate boosts in positive affect upon completion. The secondary goal is to provide the research team with greater experience recruiting inpatients with an ACS, successfully completing intervention sessions, and administering psychological and medical assessments by phone.
|Condition or disease||Intervention/treatment||Phase|
|ACS - Acute Coronary Syndrome||Behavioral: Positive Psychology + Motivational Interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Positive Psychology for Acute Coronary Syndrome Patients: A proof-of Concept Feasibility Trial|
|Estimated Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Positive Psychology + Motivational Interviewing
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Behavioral: Positive Psychology + Motivational Interviewing
For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
- Number of intervention sessions completed by participants [ Time Frame: 12 weeks ]Measured by number of intervention sessions completed by participants
- Change in physical activity [ Time Frame: Baseline, 12 week ]As measured by accelerometer
- Change in medication adherence [ Time Frame: Baseline, 12 week ]Measured by SRMA, a two-item self-report medication adherence scale measuring percentage of time patients report taking their heart medications in the past one and two weeks.
- Change in dietary adherence [ Time Frame: Baseline, 12 week ]Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
- Change in positive affect [ Time Frame: Baseline, 12 week ]Measured by the Positive and Negative Affect Schedule (PANAS)
- Change in trait optimism [ Time Frame: Baseline, 12 week ]Measured by the Life Orientation Test-Revised (LOT-R)
- Change in state optimism [ Time Frame: Baseline, 12 week ]Measured by the State Optimism Scale developed by Dr. Jeff Huffman
- Change in anxiety [ Time Frame: Baseline, 12 week ]Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
- Change in depression [ Time Frame: Baseline, 12 week ]Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
- Change in physical function [ Time Frame: Baseline, 12 week ]Measured by the Duke Activity Status Index (DASI)
- Change in health-related quality of life [ Time Frame: Baseline, 12 week ]Measured by the Short Form 12 (SF-12)
- Change in adherence to health behaviors [ Time Frame: Baseline, 12 week ]Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
- Change in cardiac symptoms [ Time Frame: Baseline, 12 week ]Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study
- Change in physical activity [ Time Frame: Baseline, 12 week ]Measured by the self-report International Physical Activity Questionnaire (IPAQ)
- Change in perceived stress [ Time Frame: Baseline, 12 week ]Measured by the perceived stress scale (PSS-4) measure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062383
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Judith Moskowitz, PhD, MPH||Northwestern University|