Back to resultsPositive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (PEACE II)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive psychology intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Health behavior, Mental health
Eligibility Criteria
Inclusion Criteria:
- Adult patients admitted to one of three cardiac inpatient units at Massachusetts General Hospital.
- Primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina).
- Less-than-optimal adherence to health behaviors. This will be defined as a mean score of less than 15 on the Medical Outcomes Study Specific Adherence Scale (scores range from 3-18, with higher scores indicating better adherence).
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
- Patients not prescribed aspirin at discharge.
- Inability to communicate in English.
- Inability to participate in physical activity.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Positive psychology
Arm Description
Positive psychology intervention
Outcomes
Primary Outcome Measures
Rate of Exercise Completion
Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.
Ease of Exercises
Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.
Self-reported Psychological Impact of Exercises
Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.
Secondary Outcome Measures
Objective Psychological Impact of Exercises
Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:
Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)
Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)
Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).
Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline.
Full Information
NCT ID
NCT02004158
First Posted
December 3, 2013
Last Updated
May 2, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02004158
Brief Title
Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome
Acronym
PEACE II
Official Title
Study of a Positive Psychology Program to Improve Healthy Behaviors After an Acute Coronary Syndrome: Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this proof-of-concept study, the investigators will assess the ease and usefulness of a positive psychology program in patients with acute coronary syndrome and less-than-optimal adherence to health behaviors. The investigators believe that positive psychology (a field that studies boosting positive emotions rather than simply reducing negative emotions) will help this cardiac population to be more healthy. The investigators want to determine whether this positive psychology program has the potential to be an adjunctive treatment for cardiac populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute coronary syndrome, Health behavior, Mental health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive psychology
Arm Type
Experimental
Arm Description
Positive psychology intervention
Intervention Type
Behavioral
Intervention Name(s)
Positive psychology intervention
Primary Outcome Measure Information:
Title
Rate of Exercise Completion
Description
Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.
Time Frame
8 weeks
Title
Ease of Exercises
Description
Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.
Time Frame
8 weeks
Title
Self-reported Psychological Impact of Exercises
Description
Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Objective Psychological Impact of Exercises
Description
Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:
Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)
Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)
Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).
Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients admitted to one of three cardiac inpatient units at Massachusetts General Hospital.
Primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina).
Less-than-optimal adherence to health behaviors. This will be defined as a mean score of less than 15 on the Medical Outcomes Study Specific Adherence Scale (scores range from 3-18, with higher scores indicating better adherence).
Exclusion Criteria:
Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
Patients not prescribed aspirin at discharge.
Inability to communicate in English.
Inability to participate in physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome
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