Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (PEACE II)
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.
|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|
- 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.
- 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:
- 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.
- 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.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Positive psychology
Positive psychology intervention
|Behavioral: Positive psychology intervention|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004158
|Contact: Jeff Huffman, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jeff Huffman, MD 617-724-2910 email@example.com|
|Principal Investigator:||Jeff Huffman, MD||Massachusetts General Hospital|