Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (PEACE II)
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ClinicalTrials.gov Identifier: NCT02004158 |
Recruitment Status
:
Completed
First Posted
: December 6, 2013
Results First Posted
: July 24, 2017
Last Update Posted
: July 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Behavioral: Positive psychology intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of a Positive Psychology Program to Improve Healthy Behaviors After an Acute Coronary Syndrome: Proof of Concept Study |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Positive psychology
Positive psychology intervention
|
Behavioral: Positive psychology intervention |
- Rate of Exercise Completion [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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.
- Objective Psychological Impact of Exercises [ Time Frame: 8 weeks ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004158
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Jeff Huffman, MD | Massachusetts General Hospital |
Responsible Party: | Jeff C. Huffman, MD, Director, Cardiac Psychiatry Research Program, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT02004158 History of Changes |
Other Study ID Numbers: |
2013P001961 1R01HL113272-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 6, 2013 Key Record Dates |
Results First Posted: | July 24, 2017 |
Last Update Posted: | July 24, 2017 |
Last Verified: | May 2017 |
Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
Acute coronary syndrome Health behavior Mental health |
Additional relevant MeSH terms:
Syndrome Acute Coronary Syndrome Disease Pathologic Processes |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |