Multiple Sclerosis
Conditions
Keywords
Positive psychology, Positive affect
Brief summary
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.
Interventions
BEHAVIORALPositive psychology
5-week positive psychology intervention
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Positive Psychology (PP) Intervention | Five weeks | Percentage of subjects who completed at least four of the five PP exercises. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Ratings of Ease of Completion of PP Exercises | Five weeks | Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercises provided by subjects with 0 being very difficult to complete and 10 being very easy to complete. |
| Subject Ratings of Utility of PP Exercises | Five weeks | Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of utility of PP exercises provided by subjects, with 0 being not helpful and 10 being very helpful. |
| Changes in Affect From Baseline to Five Weeks | Five weeks | Measured by the Positive and Negative Affect Schedule (PANAS). PANAS is comprised of two 10-item mood scales, one measuring positive affect and the other measuring negative affect. Scores on the positive affect scale range form 10-50. Higher scores are associated with greater positive affect. Scores on the negative affect scale range from 10-50, with lower scores representing lower levels of negative affect. |
| Changes in Trait Optimism From Baseline to Five Weeks | Five weeks | Measured by the Life Orientation Test - Revised (LOT-R). Lot-R is a 6-item measure of trait optimism and pessimism. Scores range from 0-24. Higher scores are associated with greater optimism. |
| Changes in Physical, Mental and Social Health From Baseline to Five Weeks | Five weeks | Measured by Neuro-QoL. Neuro-QoL uses computer adaptive testing to assess 11 domains of physical, mental and social health including Ability to participate in Social Roles and Activities, Anxiety, Cognitive Function, Depression, Emotional and Behavioral Dyscontrol, Fatigue, Lower Extremity Function, Positive Affect and Well-being, Satisfaction with Social Roles and Activities, Stigma and Upper Extremity Function. Neuro-QoL generates T scores with a mean of 50 and standard deviation (SD) of 10, based on the norming sample used, for each domain. All Neuro-QoL domains are scored such that a high score reflects more of what is being measured. |
| Changes in Resilience From Baseline to Five Weeks | Five weeks | Measured by the Brief Resilience Scale (BRS). BRS is a 6-item measure of resilience with scores ranging from 1-5. Higher scores are associated with greater resilience. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.9 Years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
None listed