Clinical trial NCT06891937: Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis
Official title: A Self-directed Positive Psychology Intervention for Individuals With Newly Diagnosed Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Positive psychology
Positive affect
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of PP exercises completed by subjects
timeFrame: Five weeks
Secondary outcomes:
measure: Subject ratings of ease of completion of PP exercises
timeFrame: Five weeks
measure: Subject ratings of utility of PP exercises
timeFrame: Five weeks
measure: Changes in affect
timeFrame: Five weeks
measure: Change in trait optimism
timeFrame: Five weeks
measure: Changes in physical, mental and social health
timeFrame: Five weeks
measure: Changes in resilience
timeFrame: Five weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham MS Center
state: Massachusetts
Study officials:
References: