Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PEACE II  

Official title:

Study of a Positive Psychology Program to Improve Healthy Behaviors After an Acute Coronary Syndrome: Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004158
• Other study ID #: 2013P001961
• Secondary ID: 1R01HL113272-01A
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: November 3, 2014
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• Positive psychology intervention

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of exercise completion	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.	8 weeks	No
Primary	Ease of exercises	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.	8 weeks	No
Primary	Self-reported psychological impact of exercises	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.	8 weeks	No
Secondary	Objective psychological impact of exercises	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); Gratitude Questionnaires-6 (scores range from 6-42; a high score means higher gratitude); 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.	8 weeks	No
Secondary	Feasibility of step counter & pill counter devices	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.	8 weeks	No