Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04062383
Status:
TERMINATED
Last Update Posted:
2022-12-01
First Post:
2018-10-26
Brief Title:
Positive Emotions After Acute Coronary Events at Northwestern University
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Positive Psychology for Acute Coronary Syndrome Patients A proof-of Concept Feasibility Trial
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In-person recruitment deemed not feasible due to COVID
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEACE-NU
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
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 weeks session content and a discussion of the rationale and assignment of the next weeks exerciseassignment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None