Trial Outcomes & Findings for Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis (NCT NCT06891937)
NCT ID: NCT06891937
Last Updated: 2026-01-22
Results Overview
Percentage of subjects who completed at least four of the five PP exercises.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Five weeks
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Intervention
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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 study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Intervention
n=15 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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 study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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
|
36.7 Years
STANDARD_DEVIATION 7.8 • n=270 Participants
|
37.9 Years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
37.3 Years
STANDARD_DEVIATION 8.62 • n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=270 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Five weeksPercentage of subjects who completed at least four of the five PP exercises.
Outcome measures
| Measure |
Intervention
n=15 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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 study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Feasibility of the Positive Psychology (PP) Intervention
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Five weeksPopulation: Data were included from all participants who completed each exercise, even if the participant did not complete at least four of the five PP exercises required to demonstrate feasibility.
Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercises provided by subjects with 0 being very difficult to complete and 10 being very easy to complete.
Outcome measures
| Measure |
Intervention
n=12 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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
|
7.2 score on a scale
Interval 6.2 to 8.0
|
7.5 score on a scale
Interval 6.6 to 8.4
|
SECONDARY outcome
Timeframe: Five weeksPopulation: Data were included from all participants who completed each exercise, even if the participant did not complete at least four of the five PP exercises required to demonstrate feasibility.
Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of utility of PP exercises provided by subjects, with 0 being not helpful and 10 being very helpful.
Outcome measures
| Measure |
Intervention
n=12 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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 Utility of PP Exercises
|
7.1 score on a scale
Interval 6.2 to 7.9
|
7.9 score on a scale
Interval 7.3 to 8.6
|
SECONDARY outcome
Timeframe: Five weeksMeasured 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 form 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=10 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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 From Baseline to Five Weeks
Changes in PANAS Positive Affect
|
4.75 score on a scale
Interval 1.77 to 7.72
|
-1.93 score on a scale
Interval -4.75 to 0.89
|
|
Changes in Affect From Baseline to Five Weeks
Changes in PANAS Negative Affect
|
-2.47 score on a scale
Interval -5.34 to 0.4
|
0.74 score on a scale
Interval -1.74 to 3.23
|
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=10 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Changes in Trait Optimism From Baseline to Five Weeks
|
1.77 score on a scale
Interval 0.06 to 3.48
|
-1.26 score on a scale
Interval -2.76 to 0.24
|
SECONDARY outcome
Timeframe: Five weeksMeasured by Neuro-QoL. Neuro-QoL uses computer adaptive testing to assess 11 domains of physical, mental and social health including Ability to participate in Social Roles and Activities, Anxiety, Cognitive Function, Depression, Emotional and Behavioral Dyscontrol, Fatigue, Lower Extremity Function, Positive Affect and Well-being, Satisfaction with Social Roles and Activities, Stigma and Upper Extremity Function. Neuro-QoL generates T scores with a mean of 50 and standard deviation (SD) of 10, based on the norming sample used, for each domain. All Neuro-QoL domains are scored such that a high score reflects more of what is being measured.
Outcome measures
| Measure |
Intervention
n=10 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Lower Extremity Function
|
1.3 score on a scale
Interval -0.72 to 3.31
|
-1.4 score on a scale
Interval -3.25 to 0.44
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Cognitive Function
|
0.82 score on a scale
Interval -2.05 to 3.7
|
4.45 score on a scale
Interval 1.93 to 6.97
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Emotional and Behavioral Dyscontrol
|
-3.27 score on a scale
Interval -7.89 to 1.35
|
-0.96 score on a scale
Interval -5.17 to 3.25
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Fatigue
|
-2.22 score on a scale
Interval -5.13 to 0.69
|
0.4 score on a scale
Interval -2.29 to 3.09
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Ability to Participate in Social Roles
|
2.41 score on a scale
Interval -0.9 to 5.71
|
0.62 score on a scale
Interval -2.39 to 3.63
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Positive Affect
|
1.01 score on a scale
Interval -1.16 to 3.18
|
-0.85 score on a scale
Interval -2.77 to 1.07
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Satisfaction with Social Roles
|
3.42 score on a scale
Interval 0.37 to 6.47
|
0.52 score on a scale
Interval -2.24 to 3.27
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neur-QoL Upper Extremity Function
|
1.71 score on a scale
Interval -0.72 to 4.13
|
-1.28 score on a scale
Interval -3.42 to 0.86
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Anxiety
|
-1.62 score on a scale
Interval -4.95 to 1.71
|
-0.66 score on a scale
Interval -3.58 to 2.27
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Depression
|
-1.46 score on a scale
Interval -3.97 to 1.04
|
0.02 score on a scale
Interval -2.19 to 2.22
|
|
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Changes in Neuro-QoL Stigma
|
-1.48 score on a scale
Interval -3.8 to 0.83
|
-1.47 score on a scale
Interval -3.5 to 0.57
|
SECONDARY outcome
Timeframe: Five weeksMeasured by the Brief Resilience Scale (BRS). 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=10 Participants
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP 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=11 Participants
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
Positive psychology: 5-week positive psychology intervention
|
|---|---|---|
|
Changes in Resilience From Baseline to Five Weeks
|
0.2 score on a scale
Interval -0.1 to 0.49
|
0.21 score on a scale
Interval -0.06 to 0.48
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control - No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control - Intervention
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