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Positive Emotions After Acute Coronary Events at Northwestern University (PEACE-NU)

Primary Purpose

ACS - Acute Coronary Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Psychology + Motivational Interviewing

About this trial

This is an interventional supportive care trial for ACS - Acute Coronary Syndrome focused on measuring ACS, Positive Psychology, Motivational Interviewing, Positive emotions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive Psychology + Motivational Interviewing

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of intervention sessions completed by participants

Measured by number of intervention sessions completed by participants

Secondary Outcome Measures

Change in physical activity

As measured by accelerometer

Change in medication adherence

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

Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.

Change in positive affect

Measured by the Positive and Negative Affect Schedule (PANAS)

Change in trait optimism

Measured by the Life Orientation Test-Revised (LOT-R)

Change in state optimism

Measured by the State Optimism Scale developed by Dr. Jeff Huffman

Change in anxiety

Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)

Change in depression

Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)

Change in physical function

Measured by the Duke Activity Status Index (DASI)

Change in health-related quality of life

Measured by the Short Form 12 (SF-12)

Change in adherence to health behaviors

Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)

Change in cardiac symptoms

Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study

Change in physical activity

Measured by the self-report International Physical Activity Questionnaire (IPAQ)

Change in perceived stress

Measured by the perceived stress scale (PSS-4) measure

Full Information

NCT ID

NCT04062383

First Posted

October 26, 2018

Last Updated

November 28, 2022

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04062383

Brief Title

Positive Emotions After Acute Coronary Events at Northwestern University

Acronym

PEACE-NU

Official Title

Positive Psychology for Acute Coronary Syndrome Patients: A proof-of Concept Feasibility Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

In-person recruitment deemed not feasible due to COVID

Study Start Date

February 24, 2020 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ACS - Acute Coronary Syndrome

Keywords

ACS, Positive Psychology, Motivational Interviewing, Positive emotions

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Positive Psychology + Motivational Interviewing

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Positive Psychology + Motivational Interviewing

Intervention Description

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 Measure Information:

Title

Number of intervention sessions completed by participants

Description

Measured by number of intervention sessions completed by participants

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in physical activity

Description

As measured by accelerometer

Time Frame

Baseline, 12 week

Title

Change in medication adherence

Description

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.

Time Frame

Baseline, 12 week

Title

Change in dietary adherence

Description

Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.

Time Frame

Baseline, 12 week

Title

Change in positive affect

Description

Measured by the Positive and Negative Affect Schedule (PANAS)

Time Frame

Baseline, 12 week

Title

Change in trait optimism

Description

Measured by the Life Orientation Test-Revised (LOT-R)

Time Frame

Baseline, 12 week

Title

Change in state optimism

Description

Measured by the State Optimism Scale developed by Dr. Jeff Huffman

Time Frame

Baseline, 12 week

Title

Change in anxiety

Description

Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)

Time Frame

Baseline, 12 week

Title

Change in depression

Description

Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)

Time Frame

Baseline, 12 week

Title

Change in physical function

Description

Measured by the Duke Activity Status Index (DASI)

Time Frame

Baseline, 12 week

Title

Change in health-related quality of life

Description

Measured by the Short Form 12 (SF-12)

Time Frame

Baseline, 12 week

Title

Change in adherence to health behaviors

Description

Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)

Time Frame

Baseline, 12 week

Title

Change in cardiac symptoms

Description

Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study

Time Frame

Baseline, 12 week

Title

Change in physical activity

Description

Measured by the self-report International Physical Activity Questionnaire (IPAQ)

Time Frame

Baseline, 12 week

Title

Change in perceived stress

Description

Measured by the perceived stress scale (PSS-4) measure

Time Frame

Baseline, 12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Moskowitz, PhD, MPH

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11315248

Citation

Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.

Results Reference

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PubMed Identifier

3397865

Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

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PubMed Identifier

21115758

Citation

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PubMed Identifier

22018588

Citation

Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

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Citation

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Positive Emotions After Acute Coronary Events at Northwestern University

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