A Positive Psychology Intervention for Patients With Multiple Sclerosi
A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Positive Psychology
Results by group
Percentage of PP Exercises Completed by Subjects
Five weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 93 percentage of exercises completed | 15 | |
| Waitlist Control | 93 percentage of exercises completed | 15 |
Intervention
Waitlist Control
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Intervention | 15 | 0 (0.0%) | 0 |
| Waitlist Control | 15 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of PP Exercises Completed by Subjects
Five weeks
Physical function
Other measures (9)
Subject Ratings of Ease of Completion of PP Exercises
Five weeks
Physical functionChanges in Affect
Five weeks
Mood and sleepChange in Trait Optimism
Five weeks
Change in Depression
Five weeks
Mood and sleepChange in Anxiety
Five weeks
Mood and sleepChanges in Health-related Quality of Life
Five weeks
Quality of life (reported by participants)Change in Work Productivity
Five weeks
Change in Perceived Stress
Five weeks
Change in Resilience
Five weeks
Who could take part
MS (type not specified) · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2018
Main results due
Apr 2019
Finished
Apr 2019
Results posted
Aug 2021