Clinical trial NCT03637699: A Positive Psychology Intervention for Patients With Multiple Sclerosis
Official title: A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Positive Psychology
Positive Affect
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Consortium of Multiple Sclerosis Centers
name: Massachusetts General Hospital
First posted: 2018-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of PP Exercises Completed by Subjects
timeFrame: Five weeks
Secondary outcomes:
measure: Subject Ratings of Ease of Completion of PP Exercises
timeFrame: Five weeks
measure: Changes in Affect
timeFrame: Five weeks
measure: Change in Trait Optimism
timeFrame: Five weeks
measure: Change in Depression
timeFrame: Five weeks
measure: Change in Anxiety
timeFrame: Five weeks
measure: Changes in Health-related Quality of Life
timeFrame: Five weeks
measure: Change in Work Productivity
timeFrame: Five weeks
measure: Change in Perceived Stress
timeFrame: Five weeks
measure: Change in Resilience
timeFrame: Five weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: