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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 : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Judith Moskowitz, Northwestern University

Brief Summary:

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

Detailed Description:
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, a study interventionist will provide a treatment manual for the positive psychology + motivational interviewing intervention, 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 and motivational interviewing portions of the program, and will be assigned the first exercise. Participants 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 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, 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 the follow-up timepoint as an objective measure of physical activity, which they will return by mail to the study staff.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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 : January 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of intervention sessions completed by participants [ Time Frame: 12 weeks ]
    Measured by number of intervention sessions completed by participants


Secondary Outcome Measures :
  1. Change in physical activity [ Time Frame: Baseline, 12 week ]
    As measured by accelerometer

  2. 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.

  3. 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.

  4. Change in positive affect [ Time Frame: Baseline, 12 week ]
    Measured by the Positive and Negative Affect Schedule (PANAS)

  5. Change in trait optimism [ Time Frame: Baseline, 12 week ]
    Measured by the Life Orientation Test-Revised (LOT-R)

  6. Change in state optimism [ Time Frame: Baseline, 12 week ]
    Measured by the State Optimism Scale developed by Dr. Jeff Huffman

  7. Change in anxiety [ Time Frame: Baseline, 12 week ]
    Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)

  8. Change in depression [ Time Frame: Baseline, 12 week ]
    Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)

  9. Change in physical function [ Time Frame: Baseline, 12 week ]
    Measured by the Duke Activity Status Index (DASI)

  10. Change in health-related quality of life [ Time Frame: Baseline, 12 week ]
    Measured by the Short Form 12 (SF-12)

  11. 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)

  12. Change in cardiac symptoms [ Time Frame: Baseline, 12 week ]
    Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study

  13. Change in physical activity [ Time Frame: Baseline, 12 week ]
    Measured by the self-report International Physical Activity Questionnaire (IPAQ)

  14. Change in perceived stress [ Time Frame: Baseline, 12 week ]
    Measured by the perceived stress scale (PSS-4) measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients must meet at least two of three World Health Organization criteria for an acute MI: typical chest pain, elevated cardiac enzymes, and electrocardiographic changes consistent with MI. For UA, participants must have new-onset angina within 2 months, exacerbation of previous angina with rest or with minimal exercise, or angina within 2 weeks of MI.
  • Suboptimal adherence to health behaviors: eligible patients must meet a total item score of <15 (suboptimal) based on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items OR a total item score of 15 and a physical activity item score of <5.

Exclusion Criteria:

  • Cognitive deficits, assessed via a 6-item cognitive screen,33 used to assess appropriate participation of medically ill patients in research studies and defined by a score of < 4.
  • Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and Dr. James Flaherty.
  • Individuals who have undergone coronary artery bypass surgery, or any open heart surgery, in the past 1 year.
  • 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.

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Judith Moskowitz, PhD, MPH Northwestern University
Publications:

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Responsible Party: Judith Moskowitz, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04062383    
Other Study ID Numbers: STU00208301
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Moskowitz, Northwestern University:
ACS
Positive Psychology
Motivational Interviewing
Positive emotions
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases