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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02004158
First Posted: December 6, 2013
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
  Purpose
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 Intervention
Acute Coronary Syndrome Behavioral: Positive psychology intervention

Study Type: Interventional
Study Design: 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

Further study details as provided by Jeff C. Huffman, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 23
Study Start Date: November 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive psychology
Positive psychology intervention
Behavioral: Positive psychology intervention

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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

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 Submitted: December 3, 2013
First Posted: December 6, 2013
Results First Submitted: March 22, 2017
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