Multiple SclerosisNCT07211516
Relationship Between Cognition, Workforce Participation and Well-Being in Individuals With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Region Gävleborg at 1 site in Sweden.
Trial summary
Multiple sclerosis (MS) is a chronic neurodegenerative disease and a leading cause of reduced workforce participation due to neurological illness in Western countries. Over the past 30 years, new treatments have reduced symptom burden, allowing patients to stay in the workforce longer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of working age with MS in Region Gävleborg who have performed a neuropsychological assessment during the 5 years prior to study start and who are not suffering from other diagnosis which impact their work ability to a large extent.
Who may be able to join
- Multiple sclerosis Age between 18-65 Performed a neuropsychological assessment at the Neurology department at Gävle Hospital during the last 5 years (counting from study start) -
Who cannot join
- Other diagnosis hindering work participation more than MS
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Gävle hospital
Gävle
Natascha Ekdahl, +4626278023, natascha.ekdahl@regiongavleborg.se
About this study
Official title: Improving Workforce Participation and Well-Being in Individuals With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic neurodegenerative disease and a leading cause of reduced workforce participation due to neurological illness in Western countries. Over the past 30 years, new treatments have reduced symptom burden, allowing patients to stay in the workforce longer. However, fatigue and cognitive impairments remain major barriers to work capacity. This project aims to examine factors important for work ability and well-being in persons with MS and cognitive impairments. The specific research questions are:
- How do job type and opportunities for workplace adaptations influence work ability and well-being in individuals with MS and cognitive impairments?
- What are the associations between cognitive function in MS and work ability as well as well-being? The investigators plan to collect data on patients with MS who have undergone a neuropsychological assessment at the neurology clinic in Region Gävleborg over a five year period. Approximately 100 patients are eligible for participation. Data will be collected through surveys and by extracting information from medical records. The surveys include questions related to well-being and work ability. Data from medical records contain data from the neuropsychological assessment, other rehabilitation interventions as well as data related to treatment and progress of MS.
The findings from the study aim to enhance work-oriented rehabilitation and provide a deeper understanding of how to support individuals with MS in maintaining employment and overall well-being
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MS and of working age (18-65) who have been referred to neuropsychological evaluation. | Time of neuropsychological assessment from 5 years before until study start. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work participation
Percentage of full-time work. 100 % full-time work and 0% is not working at all.
Measured: Baseline
Hospital anxiety and depression scale (HADS)
Self-assessment of anxiety and depression. Consists of two scales measuring the probability of having anxiety and depression respectively. Min score 0, max 21 for each scale. Higher scores indicate higher probability of anxiety/depression.
Measured: Baseline
WHO-5 Well-Being Index
Overall rating of well-being. The WHO-5 score range is a raw score of 0-25, which is then multiplied by 4 to get a percentage score of 0-100. Higher score indicates higher well-being.
Measured: Baseline
Brief index of job satisfaction (BIAJS)
The Brief Index of Affective Job Satisfaction (BIAJS) has a score range of 1 to 5 for each of its four items, based on a 5-point Likert scale where 1 is "strongly disagree" and 5 is "strongly agree". The total BIAJS score is the sum of these four items, resulting in a possible range from 4 to 20, with higher scores indicating greater affective job satisfaction.
Measured: Baseline
Secondary outcomes (2)
Work-life balance
Questions from the subscale "Quantitative demands" of the Copenhagen Psychosocial Questionnaire (COPSOQ-III) related to the demands of work. The COPSOQ-III uses Likert-like scales, and its items are coded with values of 0, 25, 50, 75, and 100 to achieve a 0-100 scale. Higher scores indicate more demands.
Measured: Baseline
Can-Work-S
Three questions from a questionnaire developed to measure work-life balance after cancer. Each item ranges from 1 to 5 with higher scores indicating worse work-life balance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Gävleborg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gavle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211516
- Sponsor's protocol ID
- MSCogWork2
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with the conditions set by the ethical review board, individual participant data (IPD) cannot be shared with other researchers. However, aggregated data are available upon reasonable reques
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Workforce Participation and Well-Being in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07211516
- Acronym / sponsor ID
- MSCogWork2
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Region GävleborgUniversity, hospital or other
- Collaborators
- University of Gavle
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) is a chronic neurodegenerative disease and a leading cause of reduced workforce participation due to neurological illness in Western countries. Over the past 30 years, new treatments have reduced symptom burden, allowing patients to stay in the workforce longer. However, fatigue and cognitive impairments remain major barriers to work capacity. This project aims to examine factors important for work ability and well-being in persons with MS and cognitive impairments. The specific research questions are:
- How do job type and opportunities for workplace adaptations influence work ability and well-being in individuals with MS and cognitive impairments?
- What are the associations between cognitive function in MS and work ability as well as well-being? The investigators plan to collect data on patients with MS who have undergone a neuropsychological assessment at the neurology clinic in Region Gävleborg over a five year period. Approximately 100 patients are eligible for participation. Data will be collected through surveys and by extracting information from medical records. The surveys include questions related to well-being and work ability. Data from medical records contain data from the neuropsychological assessment, other rehabilitation interventions as well as data related to treatment and progress of MS.
The findings from the study aim to enhance work-oriented rehabilitation and provide a deeper understanding of how to support individuals with MS in maintaining employment and overall well-being
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MS and of working age (18-65) who have been referred to neuropsychological evaluation. | – | –Time of neuropsychological assessment from 5 years before until study start. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of working age with MS in Region Gävleborg who have performed a neuropsychological assessment during the 5 years prior to study start and who are not suffering from other diagnosis which impact their work ability to a large extent.
Key inclusion criteria (1 listed)
- Multiple sclerosis Age between 18-65 Performed a neuropsychological assessment at the Neurology department at Gävle Hospital during the last 5 years (counting from study start) -
Key exclusion criteria (2 listed)
- Other diagnosis hindering work participation more than MS
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Work participation
Time frame: Baseline
Percentage of full-time work. 100 % full-time work and 0% is not working at all.
Hospital anxiety and depression scale (HADS)
Time frame: Baseline
Self-assessment of anxiety and depression. Consists of two scales measuring the probability of having anxiety and depression respectively. Min score 0, max 21 for each scale. Higher scores indicate higher probability of anxiety/depression.
WHO-5 Well-Being Index
Time frame: Baseline
Overall rating of well-being. The WHO-5 score range is a raw score of 0-25, which is then multiplied by 4 to get a percentage score of 0-100. Higher score indicates higher well-being.
Brief index of job satisfaction (BIAJS)
Time frame: Baseline
The Brief Index of Affective Job Satisfaction (BIAJS) has a score range of 1 to 5 for each of its four items, based on a 5-point Likert scale where 1 is "strongly disagree" and 5 is "strongly agree". The total BIAJS score is the sum of these four items, resulting in a possible range from 4 to 20, with higher scores indicating greater affective job satisfaction.
2 secondary outcomes
Work-life balance
Time frame: Baseline
Can-Work-S
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No. To comply with the conditions set by the ethical review board, individual participant data (IPD) cannot be shared with other researchers. However, aggregated data are available upon reasonable reques
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Region Gävleborg at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natascha Ekdahl (+4626278023, natascha.ekdahl@regiongavleborg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work participation (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.