Self-Directed Positive Psychology Intervention for Newly Diagnosed Mul
A Self-directed Positive Psychology Intervention for Individuals With Newly Diagnosed 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
Feasibility of the Positive Psychology (PP) Intervention
Five weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 10 Participants | 15 | |
| Waitlist Control | 11 Participants | 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 - No Intervention | 15 | 0 (0.0%) | 0 |
| Waitlist Control - Intervention | 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
Feasibility of the Positive Psychology (PP) Intervention
Five weeks
Physical functionFeasibility
Other measures (6)
Subject Ratings of Ease of Completion of PP Exercises
Five weeks
Physical functionSubject Ratings of Utility of PP Exercises
Five weeks
Physical functionChanges in Affect From Baseline to Five Weeks
Five weeks
Mood and sleepChanges in Trait Optimism From Baseline to Five Weeks
Five weeks
Changes in Physical, Mental and Social Health From Baseline to Five Weeks
Five weeks
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Changes in Resilience From Baseline to Five Weeks
Five weeks
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* Diagnosis of MS according to the McDonald 2017 diagnostic criteria * Onset of disease within the last 2 years * Ability to speak, read and write in English
Exclusion criteria
• Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits 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
The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are: * Is a five-week self-directed PP training intervention feasible and acceptable to individuals with newly diagnosed MS? * Does the completion of a five-week self-directed PP training intervention improve positive affect, emotional function and health-related quality of life (HRQOL) in individuals with newly diagnosed MS? * Are improvements in positive affect, emotional function and HRQOL maintained after the completion of the intervention? Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study. Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.
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History
Started
Jul 2022
Main results due
Oct 2024
Finished
Oct 2024
Results posted
Jan 2026