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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02004158
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Behavioral: Positive psychology intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• 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: Nov 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Positive psychology Positive psychology intervention	Behavioral: Positive psychology intervention

Outcome Measures

Primary Outcome Measures

1. Rate of Exercise Completion [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeff C. Huffman, MD, Director, Cardiac Psychiatry Research Program, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02004158
• Other Study ID Numbers: 2013P001961; 1R01HL113272-01A1
• First Posted: Dec 6, 2013
• Last Update Posted: Jul 24, 2017
• Last Verified: May 1, 2017

• Keywords provided by Jeff C. Huffman, MD, Director, Cardiac Psychiatry Research Program, Massachusetts General Hospital: Acute coronary syndrome; Health behavior; Mental health
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

Participant Flow

Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
Period Title: Overall Study
STARTED	23
COMPLETED	20
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
Overall Participants	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (11.7)
Sex: Female, Male (Count of Participants)
Female	11 47.8%
Male	12 52.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 4.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 8.7%
White	18 78.3%
More than one race	1 4.3%
Unknown or Not Reported	1 4.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
Measure Participants	23
Number [Participants]	17 73.9%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
Measure Participants	23
Mean (Standard Deviation) [scores on a scale]	7.4 (2.1)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
Measure Participants	23
Optimism	7.9 (1.5)
Happiness	8.0 (1.6)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Psychology	Positive Psychology
Arm/Group Description	Positive psychology intervention (Baseline data)	Positive psychology intervention (8 week data)
Measure Participants	20	20
LOT-R	23.5 (4.8)	23.0 (5.8)
PANAS	35.1 (7.9)	38.2 (8.6)
HADS	13.4 (8.9)	9.0 (5.6)

Adverse Events

Time Frame	11 months (duration of study)
Arm/Group Title	Positive Psychology
Arm/Group Description	Positive psychology intervention
All Cause Mortality
	Positive Psychology
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Positive Psychology
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Other (Not Including Serious) Adverse Events
	Positive Psychology
	Affected / at Risk (%)	# Events
Total	0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.