Multiple Sclerosis Multiple Sclerosis
Conditions
Interventions
All interventions will be performed on mobile devices and can thus be done at 
home. Group 1 will undergo 12 weeks of conscientiousness training, which 
consists of a pre-session and two booster sessions with a coach to explain 
goals, values and the training application, weekly telephone calls, as well as the self-use of the 
smartphone application C.Coach between sessions to track goals and values. 
Group 2 will undergo 12 weeks of sham intervention, consisting of a pre-session 
and two booster sessions with a coach to discuss reflective questions on various areas of life, weekly telephone calls, and the self-use of the smartphone application Daily Notes to journal about refl
intervention, where they are asked to perform two 60-minutes training sessions 
per week for the duration of 6 weeks using the CR training application BrainHQ.
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Confirmed relapsing remitting or secondary progressive MS diagnosis - Expanded Disability Status Scale score = 3 months - Unchanged disease modifying therapy for >= 2 months at time of inclusion - Age 18-65 years - Language Dutch, English or German for each centre respectively
Exclusion criteria
Exclusion criteria: - Current of prior brain trauma or neurological condition (other than MS) - Psychiatric disorder that heavily impacts cognitive and/or daily functioning - Medication intake and/or substance abuse that has an influence on cognitive functioning - For Dutch subsample undergoing MRI: Contradiction for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint will be changes between baseline and post-intervention on processing speed task and improved cognitive functioning in daily life in PwMS in the intervention group compared to PwMS in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoints, changes between baseline and post-intervention on goal attainment, meaning of life, fatigue, depression, anxiety, cognitive functioning, functional brain neworks and social support in PwMS in the intervention group (conscientiousness training prior to CR) compared to PwMS in the control group (sham intervention prior to CR) will be studied. | — |
Countries
Netherlands, Switzerland, United States
Contacts
Public ContactP Zuber
Universiteit Leiden
Outcome results
None listed