Skip to main content
Clinical Trials/NCT03637699
NCT03637699
Completed
Not Applicable

A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis

Brigham and Women's Hospital1 site in 1 country30 target enrollmentMarch 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Brigham and Women's Hospital
Enrollment
30
Locations
1
Primary Endpoint
Percentage of PP Exercises Completed by Subjects
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 12, 2018
End Date
April 9, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bonnie Ilene Glanz

Research Associate

Brigham and Women's Hospital

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.

Outcomes

Primary Outcomes

Percentage of PP Exercises Completed by Subjects

Time Frame: Five weeks

Measured by percentage of PP exercises completed by subjects.

Secondary Outcomes

  • Change in Trait Optimism(Five weeks)
  • Changes in Affect(Five weeks)
  • Change in Depression(Five weeks)
  • Change in Anxiety(Five weeks)
  • Change in Resilience(Five weeks)
  • Subject Ratings of Ease of Completion of PP Exercises(Five weeks)
  • Change in Work Productivity(Five weeks)
  • Change in Perceived Stress(Five weeks)
  • Changes in Health-related Quality of Life(Five weeks)

Study Sites (1)

Loading locations...

Similar Trials