Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis

A Self-directed Positive Psychology Intervention for Individuals With Newly Diagnosed Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Positive psychology

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham MS Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Positive psychology; 5-week positive psychology intervention
Placebo Comparator: 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.	Behavioral: Positive psychology; 5-week positive psychology intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Positive Psychology (PP) Intervention	Percentage of subjects who completed at least four of the five PP exercises.	Five weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Five weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Positive psychology; Positive affect
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Behavioral Disciplines and Activities; Behavioral Sciences; Psychology; Psychology, Positive
• Other Study ID Numbers: 2021P003100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No