An interventional study of Positive psychology in Multiple Sclerosis, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are:
Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study.
Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Positive psychology
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.
Behavioral: Positive psychology
5-week positive psychology intervention
Feasibility of the Positive Psychology (PP) Intervention
Percentage of subjects who completed at least four of the five PP exercises.
Time frame: Five weeks
Subject Ratings of Ease of Completion of PP Exercises
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.
Time frame: Five weeks
Subject Ratings of Utility of PP Exercises
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.
Time frame: Five weeks
Changes in Affect From Baseline to Five Weeks
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 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.
Time frame: Five weeks
Changes in Trait Optimism From Baseline to Five Weeks
Measured 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.
Time frame: Five weeks
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Measured 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.
Time frame: Five weeks
Changes in Resilience From Baseline to Five Weeks
Measured 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.
Time frame: Five weeks
| Milestone | Intervention | Waitlist Control |
|---|---|---|
| Started | 15 | 15 |
| Completed | 10 | 11 |
| Not completed | 5 | 4 |
Percentage of subjects who completed at least four of the five PP exercises.
| Participants | Intervention | Waitlist Control |
|---|---|---|
| Feasibility of the Positive Psychology (PP) Intervention | 10 | 11 |
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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Subject Ratings of Ease of Completion of PP Exercises | 7.2 (6.2 to 8.0) | 7.5 (6.6 to 8.4) |
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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Subject Ratings of Utility of PP Exercises | 7.1 (6.2 to 7.9) | 7.9 (7.3 to 8.6) |
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 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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Changes in PANAS Positive Affect | 4.75 (1.77 to 7.72) | -1.93 (-4.75 to 0.89) |
| Changes in PANAS Negative Affect | -2.47 (-5.34 to 0.4) | 0.74 (-1.74 to 3.23) |
Measured 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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Changes in Trait Optimism From Baseline to Five Weeks | 1.77 (0.06 to 3.48) | -1.26 (-2.76 to 0.24) |
Measured 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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Changes in Neuro-QoL Ability to Participate in Social Roles | 2.41 (-0.9 to 5.71) | 0.62 (-2.39 to 3.63) |
| Changes in Neuro-QoL Cognitive Function | 0.82 (-2.05 to 3.7) | 4.45 (1.93 to 6.97) |
| Changes in Neuro-QoL Lower Extremity Function | 1.3 (-0.72 to 3.31) | -1.4 (-3.25 to 0.44) |
| Changes in Neuro-QoL Positive Affect | 1.01 (-1.16 to 3.18) | -0.85 (-2.77 to 1.07) |
| Changes in Neuro-QoL Satisfaction with Social Roles | 3.42 (0.37 to 6.47) | 0.52 (-2.24 to 3.27) |
| Changes in Neur-QoL Upper Extremity Function | 1.71 (-0.72 to 4.13) | -1.28 (-3.42 to 0.86) |
| Changes in Neuro-QoL Anxiety | -1.62 (-4.95 to 1.71) | -0.66 (-3.58 to 2.27) |
| Changes in Neuro-QoL Depression | -1.46 (-3.97 to 1.04) | 0.02 (-2.19 to 2.22) |
| Changes in Neuro-QoL Emotional and Behavioral Dyscontrol | -3.27 (-7.89 to 1.35) | -0.96 (-5.17 to 3.25) |
| Changes in Neuro-QoL Fatigue | -2.22 (-5.13 to 0.69) | 0.4 (-2.29 to 3.09) |
| Changes in Neuro-QoL Stigma | -1.48 (-3.8 to 0.83) | -1.47 (-3.5 to 0.57) |
Measured 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.
| score on a scale | Intervention | Waitlist Control |
|---|---|---|
| Changes in Resilience From Baseline to Five Weeks | 0.2 (-0.1 to 0.49) | 0.21 (-0.06 to 0.48) |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Waitlist Control - No Intervention | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Waitlist Control - Intervention | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(Years) | Intervention | Waitlist Control | Total |
|---|---|---|---|
| Mean | 36.7 ± 7.8 | 37.9 ± 9.6 | 37.3 ± 8.62 |
| Sex: Female, Male(Participants) | Intervention | Waitlist Control | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 6 | 7 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Waitlist Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 14 | 15 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Waitlist Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 11 | 13 | 24 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention | Waitlist Control | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
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