Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis

NCT06891937 | Completed Results

• 1 other identifier: 2021P003100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Positive psychology; Positive affect

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Positive Psychology (PP) Intervention

  Percentage of subjects who completed at least four of the five PP exercises.

  Five weeks

Secondary Outcomes (6)

• Subject Ratings of Ease of Completion of PP Exercises

  Five weeks

• Subject Ratings of Utility of PP Exercises

  Five weeks

• Changes in Affect From Baseline to Five Weeks

  Five weeks

• Changes in Trait Optimism From Baseline to Five Weeks

  Five weeks

• Changes in Physical, Mental and Social Health From Baseline to Five Weeks

  Five weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Waitlist Control

PLACEBO COMPARATOR

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

Interventions

Positive psychology BEHAVIORAL

5-week positive psychology intervention

Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits that would preclude meaningful participation in the PP exercises

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham MS Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Psychology, Positive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities

Limitations and Caveats

This study had a small sample size and numerous outcome measures. This may have limited our ability to see statistically significant changes across broader health-related quality of life outcomes.

Results Point of Contact

• Title: Bonnie Glanz, PhD
• Organization: Brigham and Women's Hospital

bglanz@bwh.harvard.edu

617-525-6574

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: July 20, 2022
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)