Trial Outcomes & Findings for A Positive Psychology Intervention for Patients With Multiple Sclerosis (NCT NCT03637699)
NCT ID: NCT03637699
Last Updated: 2021-08-16
Results Overview
Measured by percentage of PP exercises completed by subjects.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Five weeks
Results posted on
2021-08-16
Participant Flow
Participant milestones
| Measure |
Intervention
Subjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Positive Psychology Intervention for Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Intervention
n=15 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=15 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Five weeksMeasured by percentage of PP exercises completed by subjects.
Outcome measures
| Measure |
Intervention
n=15 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=15 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Percentage of PP Exercises Completed by Subjects
|
93 percentage of exercises completed
|
93 percentage of exercises completed
|
SECONDARY outcome
Timeframe: Five weeksMeasured by weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercise provided by subjects, with 0 being very difficult to complete and 10 being very easy to complete. Scores range from 0-10.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Subject Ratings of Ease of Completion of PP Exercises
Gratitude for positive events
|
9.0 score on a scale
Standard Deviation 1.3
|
8.4 score on a scale
Standard Deviation 1.9
|
|
Subject Ratings of Ease of Completion of PP Exercises
Personal strengths
|
8.1 score on a scale
Standard Deviation 2.2
|
7.5 score on a scale
Standard Deviation 2.2
|
|
Subject Ratings of Ease of Completion of PP Exercises
Gratitude letter
|
7.8 score on a scale
Standard Deviation 1.8
|
7.6 score on a scale
Standard Deviation 2.1
|
|
Subject Ratings of Ease of Completion of PP Exercises
Enjoyable and meaningful activities
|
9.1 score on a scale
Standard Deviation 1.5
|
8.2 score on a scale
Standard Deviation 1.7
|
|
Subject Ratings of Ease of Completion of PP Exercises
Remembering past successes
|
8.4 score on a scale
Standard Deviation 1.3
|
9.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Five weeksPopulation: Missing data.
Measured by the Positive and Negative Affect Schedule (PANAS). PANAS is comprised of two 10-item mood scales, one measuring positive affect and the other measuring negative affect. Scores on the Positive Affect scale range from 10-50. Higher scores are associated with greater positive affect. Scores on the Negative Affect scale range from 10-50, with lower scores representing lower levels of negative affect.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Changes in Affect
Positive affect
|
4.9 score on a scale
Standard Deviation 4.5
|
-3.2 score on a scale
Standard Deviation 5.8
|
|
Changes in Affect
Negative affect
|
-2.6 score on a scale
Standard Deviation 9.4
|
-0.3 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the Life Orientation Test - Revised (LOT-R). LOT-R is a 6-item measure of trait optimism and pessimism. Scores range from 0-24. Higher scores are associated with greater optimism.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Trait Optimism
|
2.1 score on a scale
Standard Deviation 3.4
|
-1.3 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item measure of depression with scores ranging from 20-80. Higher scores are associated with greater depression.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=12 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Depression
|
-2.1 score on a scale
Standard Deviation 2.9
|
0 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the State Trait Anxiety Inventory (STAI). STAI includes two 20-item questionnaires designed to measure the current temporary condition of "state" anxiety and the more general and longstanding condition of "trait" anxiety. Scores for each scale range from 20-80. Higher scores are associated with greater anxiety.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Anxiety
State anxiety
|
-3.2 score on a scale
Standard Deviation 6.1
|
3.4 score on a scale
Standard Deviation 8.1
|
|
Change in Anxiety
Trait anxiety
|
-3.3 score on a scale
Standard Deviation 4.9
|
2.7 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Five weeksPopulation: Missing data
Measured by the Medical Outcomes Study Short Form (SF-36). The SF-36 is a 36-item measure of health status and quality of Life. It consists of eight scaled scores and two summary scores. The lower the score, the more disability. The higher the score, the less disability. Scores for each scale range from 0-100.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Changes in Health-related Quality of Life
Physical functioning
|
-1.0 score on a scale
Standard Deviation 3.3
|
0.3 score on a scale
Standard Deviation 3.2
|
|
Changes in Health-related Quality of Life
Role physical
|
4.2 score on a scale
Standard Deviation 6.3
|
1.1 score on a scale
Standard Deviation 9.0
|
|
Changes in Health-related Quality of Life
Bodily pain
|
0.1 score on a scale
Standard Deviation 8.3
|
-0.2 score on a scale
Standard Deviation 7.5
|
|
Changes in Health-related Quality of Life
General health
|
1.1 score on a scale
Standard Deviation 4.0
|
-2.9 score on a scale
Standard Deviation 3.9
|
|
Changes in Health-related Quality of Life
Vitality
|
1.4 score on a scale
Standard Deviation 4.2
|
0.3 score on a scale
Standard Deviation 7.7
|
|
Changes in Health-related Quality of Life
Social functioning
|
3.0 score on a scale
Standard Deviation 6.7
|
2.4 score on a scale
Standard Deviation 9.2
|
|
Changes in Health-related Quality of Life
Role emotional
|
-3.6 score on a scale
Standard Deviation 9.4
|
-4.3 score on a scale
Standard Deviation 12.3
|
|
Changes in Health-related Quality of Life
Mental health
|
2.9 score on a scale
Standard Deviation 4.6
|
-0.8 score on a scale
Standard Deviation 6.6
|
|
Changes in Health-related Quality of Life
Physical component summary
|
0.9 score on a scale
Standard Deviation 4.2
|
0.3 score on a scale
Standard Deviation 5.4
|
|
Changes in Health-related Quality of Life
Mental component summary
|
0.5 score on a scale
Standard Deviation 6.0
|
-1.4 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Five weeksPopulation: Work time missed, Work impairment and Overall work impairment are only completed by subjects who are employed. Missing data.
Measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). Outcomes are expressed as impairment percentages with higher scores indicating greater impairment and less productivity. Scores range from 0-100.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Work Productivity
Work time missed
|
-1.0 score on a scale
Standard Deviation 4.9
|
-1.9 score on a scale
Standard Deviation 10.8
|
|
Change in Work Productivity
Work impairment
|
1.2 score on a scale
Standard Deviation 24.7
|
3.3 score on a scale
Standard Deviation 10.3
|
|
Change in Work Productivity
Overall work impairment
|
0.1 score on a scale
Standard Deviation 22.1
|
0.5 score on a scale
Standard Deviation 15.6
|
|
Change in Work Productivity
Activity impairment
|
0 score on a scale
Standard Deviation 26.9
|
5.0 score on a scale
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the Perceived Stress Scale (PSS). The PSS is a 10-item questionnaire with scores ranging from 0-40. Higher scores are associated with greater perceived stress.
Outcome measures
| Measure |
Intervention
n=14 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Perceived Stress
|
-0.4 units on a scale
Standard Deviation 2.8
|
-1.1 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the Brief Resilience Scale (BRS). The BRS is a 6-item measure of resilience with scores ranging from 1-5. Higher scores are associated with greater resilience.
Outcome measures
| Measure |
Intervention
n=13 Participants
Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention
|
Waitlist Control
n=14 Participants
Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive Psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Change in Resilience
|
0.1 score on a scale
Standard Deviation 0.4
|
-0.3 score on a scale
Standard Deviation 0.5
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place