Trajectory of Positive Psychological States in Patients With ACS

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02298296
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Suboptimal adherence to health behaviors. This will be defined as mean item score of <15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items.
• Submaximal self-reported optimism. This will be defined as a total score of <30 on the Life Orientation Test-Revised (LOT-R) .
• Submaximal self-reported positive affect. This will be defined as a total score of <50 on the Positive and Negative Affect Schedule (PANAS) .

Exclusion Criteria

• Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
• Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi.
• Inability to communicate in English.
• Inability to participate in physical activity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in positive affect measured by self-report questionnaires	Baseline, 8 weeks	To determine the change in positive psychological states, specifically optimism and positive affect, over an 8 week period following admission for ACS as measured by the Life Orientation Questionnaire (LOT-R \[trait optimism\]), Life Orientation Questionnaire-State (LOT-RS \[state optimism\]), and the Positive and Negative Affect Schedule (PANAS \[positive affect\]).

Secondary Outcome Measures

Name	Time	Method
Change in behavior adherence measured by a self-report questionnaire	Baseline, 8 weeks	To assess changes in health behavior adherence over an 8 week period following admission for ACS using the Medical Outcomes Study-Specific Adherence Scale (MOS-SAS items on physical activity, diet, and medication).
Change in function measured by self-report questionnaires	Baseline, 8 weeks	To assess changes in functional status over an 8 week period following admission for ACS using the Women's Ischemia Syndrome Evaluation (WISE \[functional status\]) and the Short Form health survey (SF-12 \[health-related quality of life\]).