Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (PEACE II)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Behavioral: Positive psychology intervention	Not Applicable

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Positive psychology; Positive psychology intervention	Behavioral: Positive psychology intervention

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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:

   1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)
   2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)
   3. 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.

Eligibility Criteria

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

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Jeff Huffman, MD	Massachusetts General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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