Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06891937
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-20
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of PP exercises completed by subjects	Five weeks	Measured by percentage of PP exercises completed by subjects.

Secondary Outcome Measures

Name	Time	Method
Subject ratings of ease of completion of PP exercises	Five weeks	Measured by 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.
Subject ratings of utility of PP exercises	Five weeks	Measured by 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.
Changes in affect	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.
Change in trait optimism	Five weeks	Measured by the Life Orientation Test - Revised (LOT-R). Lot-R is a 6-item measure of trait optimism and pessism. Scores range from 0-24. Higher scores are associated with greater optimism.
Changes in physical, mental and social health	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 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.
Changes in resilience	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.

Trial Locations

Locations (1)

Brigham MS Center; 🇺🇸 Boston, Massachusetts, United States