Positive Emotions After Acute Coronary Events at Northwestern University

Not Applicable

Terminated

• Conditions: ACS - Acute Coronary Syndrome
• Interventions: Behavioral: Positive Psychology + Motivational Interviewing

• Registration Number: NCT04062383
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2020-02-24
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive Psychology + Motivational Interviewing	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.

Primary Outcome Measures

Name	Time	Method
Number of intervention sessions completed by participants	12 weeks	Measured by number of intervention sessions completed by participants

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline, 12 week	Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Change in positive affect	Baseline, 12 week	Measured by the Positive and Negative Affect Schedule (PANAS)
Change in trait optimism	Baseline, 12 week	Measured by the Life Orientation Test-Revised (LOT-R)
Change in physical activity	Baseline, 12 week	Measured by the self-report International Physical Activity Questionnaire (IPAQ)
Change in medication adherence	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	Baseline, 12 week	Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Change in depression	Baseline, 12 week	Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Change in physical function	Baseline, 12 week	Measured by the Duke Activity Status Index (DASI)
Change in state optimism	Baseline, 12 week	Measured by the State Optimism Scale developed by Dr. Jeff Huffman
Change in adherence to health behaviors	Baseline, 12 week	Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
Change in cardiac symptoms	Baseline, 12 week	Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study
Change in perceived stress	Baseline, 12 week	Measured by the perceived stress scale (PSS-4) measure
Change in health-related quality of life	Baseline, 12 week	Measured by the Short Form 12 (SF-12)

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States