A Positive Psychology Intervention for Patients With Multiple Sclerosis

NCT ID: NCT03637699

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-04-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: OTHER

Positive Psychology

Intervention Type: BEHAVIORAL

5-week positive psychology intervention

Waitlist Control

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.

Group Type: OTHER

Positive Psychology

Intervention Type: BEHAVIORAL

5-week positive psychology intervention

Interventions

Positive Psychology

5-week positive psychology intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consortium of Multiple Sclerosis Centers

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bonnie Ilene Glanz

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P002375

Identifier Type: -

Identifier Source: org_study_id