A Positive Psychology Intervention for Patients With Multiple Sclerosis

NCT03637699 | Completed Results

• 1 other identifier: 2017P002375
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. This pilot study will examine the tolerability and efficacy of a PP training program to increase positive affect in patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the intervention group will complete five weeks of PP exercises, one exercise per week. Subjects will also have weekly calls with the study trainer. The control group will have no study activities. In the extension phase, subjects in the control group will complete PP training as described above. The investigators will examine the tolerability of the program by calculating the proportion of subjects who complete the program. The investigators will also examine exercise-specific ratings of ease and utility to measure the acceptability of each exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing subjects in the intervention and control groups on measures of positive affect, emotional function, health-related quality of life (HRQOL) and self-reported functional activities such as work. If successful, this study will advance the use of PP as a low cost, innovative and effective tool for increasing positive affect, decreasing depression and anxiety and improving HRQOL in patients with MS.

Conditions

Multiple Sclerosis

Keywords

Positive Psychology; Positive Affect

Outcome Measures

Primary Outcomes (1)

• Percentage of PP Exercises Completed by Subjects

  Measured by percentage of PP exercises completed by subjects.

  Five weeks

Secondary Outcomes (9)

• Subject Ratings of Ease of Completion of PP Exercises

  Five weeks

• Changes in Affect

  Five weeks

• Change in Trait Optimism

  Five weeks

• Change in Depression

  Five weeks

• Change in Anxiety

  Five weeks

Study Arms (2)

Intervention

OTHER

Subjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.

Behavioral: Positive Psychology

Waitlist Control

OTHER

Subjects randomized to the waitlist control group will complete five weeks of positive psychology 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 multiple sclerosis according to the McDonald 2010 diagnostic criteria
• Age 18-65
• Ability to speak, read and write in English
• Enrollment in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital, Partners MS Center: The CLIMB Study.

You may not qualify if:

• Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Consortium of Multiple Sclerosis Centers: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

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 a large number of outcome measures which may limit the ability to see statistically significant changes in health-related quality of life and other psychological 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: August 6, 2018
• First Posted: August 20, 2018
• Study Start: March 12, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: August 16, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)