Trial Outcomes & Findings for Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome (NCT NCT02004158)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Positive Psychology Positive psychology intervention
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Psychology n=23 Participants Positive psychology intervention
Age, Continuous	60.4 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positive Psychology n=23 Participants Positive psychology intervention	Positive Psychology Positive psychology intervention (8 week data)
Rate of Exercise Completion	17 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positive Psychology n=23 Participants Positive psychology intervention	Positive Psychology Positive psychology intervention (8 week data)
Ease of Exercises	7.4 scores on a scale Standard Deviation 2.1	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positive Psychology n=23 Participants Positive psychology intervention	Positive Psychology Positive psychology intervention (8 week data)
Self-reported Psychological Impact of Exercises Optimism	7.9 points Standard Deviation 1.5	—
Self-reported Psychological Impact of Exercises Happiness	8.0 points Standard Deviation 1.6	—

SECONDARY outcome

Timeframe: 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: 1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism) 2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect) 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.

Outcome measures

Outcome measures
Measure	Positive Psychology n=20 Participants Positive psychology intervention	Positive Psychology n=20 Participants Positive psychology intervention (8 week data)
Objective Psychological Impact of Exercises LOT-R	23.5 points Standard Deviation 4.8	23.0 points Standard Deviation 5.8
Objective Psychological Impact of Exercises PANAS	35.1 points Standard Deviation 7.9	38.2 points Standard Deviation 8.6
Objective Psychological Impact of Exercises HADS	13.4 points Standard Deviation 8.9	9.0 points Standard Deviation 5.6

Adverse Events

Positive Psychology

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff Huffman

Massachusetts General Hospital

Phone: 617-724-2910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place