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

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Jeff C. Huffman, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02004158

First received: December 3, 2013

Last updated: November 3, 2014

Last verified: November 2014

History of Changes

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Healthy Living

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Rate of exercise completion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Rate of exercise completion will be measured by the number of exercises completed per subject. 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 helpfulness of the exercises (0=not helpful, 10=very helpful). 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 ] [ Designated as safety issue: No ]
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. Gratitude Questionnaires-6 (scores range from 6-42; a high score means higher gratitude)
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.
Feasibility of step counter & pill counter devices [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Feasibility of these devices is measured by the amount of data we collect from 1) a step counter used for 2 weeks and 2) a pill counter used for 8 weeks. Feasibility will be defined as receiving data from both devices from more than 80% of subjects.


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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
Study First Received:	December 3, 2013
Last Updated:	November 3, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:


Acute coronary syndrome Health behavior Mental health

Additional relevant MeSH terms:


Acute Coronary Syndrome Syndrome Angina Pectoris Cardiovascular Diseases Chest Pain Disease	Heart Diseases Myocardial Ischemia Pain Pathologic Processes Signs and Symptoms Vascular Diseases

ClinicalTrials.gov processed this record on March 02, 2015

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