Trajectory of Positive Psychological States in Patients With ACS

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).

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change in positive affect measured by self-report questionnaires

Time frame: 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 outcomes

Change in behavior adherence measured by a self-report questionnaire

Time frame: 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

Time frame: 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]).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome

Acronym: PEACEIIa

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Nov 21, 2014
Registry last updated: Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed