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

CompletedNot a drug-phase studyMS (type not specified)NCT03637699

What it found

Results posted, not judged

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

GroupValueIntervalNumber analysed
Intervention93 percentage of exercises completed15
Waitlist Control93 percentage of exercises completed15

Intervention

93

Waitlist Control

93

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Intervention150 (0.0%)0
Waitlist Control150 (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 function
  • Changes in Affect

    Five weeks

    Mood and sleep
  • Change in Trait Optimism

    Five weeks

  • Change in Depression

    Five weeks

    Mood and sleep
  • Change in Anxiety

    Five weeks

    Mood and sleep
  • Changes 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

    1. Started

      Mar 2018

    2. Main results due

      Apr 2019

    3. Finished

      Apr 2019

    4. Results posted

      Aug 2021

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