Clinical trial NCT04062383: Positive Emotions After Acute Coronary Events at Northwestern University
Official title: Positive Psychology for Acute Coronary Syndrome Patients: A proof-of Concept Feasibility Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
Keywords: ACS
Positive Psychology
Motivational Interviewing
Positive emotions
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of intervention sessions completed by participants
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in physical activity
timeFrame: Baseline, 12 week
measure: Change in medication adherence
timeFrame: Baseline, 12 week
measure: Change in dietary adherence
timeFrame: Baseline, 12 week
measure: Change in positive affect
timeFrame: Baseline, 12 week
measure: Change in trait optimism
timeFrame: Baseline, 12 week
measure: Change in state optimism
timeFrame: Baseline, 12 week
measure: Change in anxiety
timeFrame: Baseline, 12 week
measure: Change in depression
timeFrame: Baseline, 12 week
measure: Change in physical function
timeFrame: Baseline, 12 week
measure: Change in health-related quality of life
timeFrame: Baseline, 12 week
measure: Change in adherence to health behaviors
timeFrame: Baseline, 12 week
measure: Change in cardiac symptoms
timeFrame: Baseline, 12 week
measure: Change in physical activity
timeFrame: Baseline, 12 week
measure: Change in perceived stress
timeFrame: Baseline, 12 week
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith Moskowitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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