Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (PEACE II)
|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|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeff Huffman, MD||Massachusetts General Hospital|