N/A
N=30
Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT06891937 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Feasibility of the Positive Psychology (PP) Intervention — 10; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive psychology (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Positive Psychology (PP) Intervention |
10; 11 | — |
| SECONDARY Subject Ratings of Ease of Completion of PP Exercises |
7.2; 7.5 | — |
| SECONDARY Subject Ratings of Utility of PP Exercises |
7.1; 7.9 | — |
| SECONDARY Changes in Affect From Baseline to Five Weeks |
4.75; -1.93; -2.47; 0.74 | — |
| SECONDARY Changes in Trait Optimism From Baseline to Five Weeks |
1.77; -1.26 | — |
| SECONDARY Changes in Physical, Mental and Social Health From Baseline to Five Weeks |
2.41; 0.62; 0.82; 4.45; 1.3; -1.4 | — |
| SECONDARY Changes in Resilience From Baseline to Five Weeks |
0.2; 0.21 | — |
Summary
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:
* Is a five-week self-directed PP training intervention feasible and acceptable to individuals with newly diagnosed MS?
* Does the completion of a five-week self-directed PP training intervention improve positive affect, emotional function and health-related quality of life (HRQOL) in individuals with newly diagnosed MS?
* Are improvements in positive affect, emotional function and HRQOL maintained after the completion of the intervention?
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of MS according to the McDonald 2017 diagnostic criteria
- Onset of disease within the last 2 years
- Ability to speak, read and write in English
Exclusion Criteria
- Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits that would preclude meaningful participation in the PP exercises
Data sourced from ClinicalTrials.gov (NCT06891937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.