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NCT Number: NCT06966115

Optimising Access to Vocational Rehabilitation for People With Multiple Sclerosis

People with multiple sclerosis (MS) often leave the workforce prematurely due to MS symptoms and difficulties managing workplace relationships and performance. Vocational rehabilitation (VR) can improve job retention outcomes for people with MS, but there is a lack of evidence on the effectiveness of these interventions.

A psychologist and occupational therapist-delivered VR intervention was previously developed to support people with MS to remain in paid employment. This programme was tested in a community setting and within the UK National Health Service (NHS). The preliminary findings demonstrate that the intervention is highly acceptable to people with MS and their employers and helped participants with MS to meet their vocational goals. However, the study also identified various barriers (e.g., lack of staff, service structure, etc.) to delivering this programme more widely within a healthcare setting.

Because of this, patient and public involvement (PPI) representatives suggested testing the VR intervention within the services provided by MS charities. This approach could be beneficial to reach people with MS who might be in the earlier stages of the illness and looking for information or who have not considered discussing "work" with their healthcare providers.

Therefore, the VR intervention MSVR ("multiple sclerosis vocational rehabilitation") was adapted to be delivered by non-specialists working for MS charities. Over recent years, the practice of training non-specialists to deliver evidence-based and complex interventions has increased to reach communities where there is a lack of resources or to help increase the reach of these interventions.

This study aims to:

1. Explore the feasibility and acceptability of providing employment support through MS charities. 2. Determine the parameters for a future large-scale randomised controlled trial. 3. Explore the experiences of those receiving and delivering the MSVR intervention.

Sixty people with MS in paid employment will be recruited to receive support with employment tailored to their needs over six months. Participants with MS will be asked to complete a booklet of questionnaires with variables known to affect employment status.

Approximately 20 participants will be asked to participate in a feedback interview at the end of the intervention.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18
  • Can give informed consent,
  • Can communicate in English,
  • Are in paid employment (including self-employed).

Exclusion criteria

  • Planning to retire within the next 12 months.
  • Currently receiving vocational rehabilitation support from the NHS or other employer services.

Treatment and study plan

Multiple Sclerosis Vocational Rehabilitation (MSVR)

Behavioral

MSVR involves an initial assessment (including vocational goal setting), followed by up to 10 hours of individually tailored support over six months according to need. The support will focus on supporting the person with MS to remain at work by addressing topics such as:

  • Understanding MS
  • Advice on reasonable adjustments
  • Support requesting reasonable adjustments
  • Fatigue management
  • Managing cognition at work
  • Information about legal rights
  • Disclosure
  • Long-term career planning
  • Managing mood difficulties
  • Signposting to local and national resources. MSVR addresses the individual needs of the person with MS and offers advice remotely (e.g., via telephone, videoconference, or email). The sessions will be arranged at a time convenient for the person, and the support needed will vary according to the complexity of their workplace difficulties.

Primary outcomes

  1. Health-related quality of life

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    The short form 36 health survey questionnaire measures eight health constructs relating to physical and mental health. The scale ranges from 0-100, with 100 representing highest level of health and functioning, and lower scores representing higher levels of disability. This measure has a high internal consistency (Cronbach's alpha >0.80) and good test-retest reliability (>0.70).

  2. Work Productivity and Activity Impairment Questionnaire- Multiple Sclerosis

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    This questionnaire includes questions about the employment situation of the person with MS, hours missed at work due to MS, and two numerical scales measuring how MS impacts productivity at work and conducting everyday activities.

    The numeric scales range from 0 (no impact) to 10 (unable to perform an activity), where a higher score represents a larger impact of MS at work and conducting everyday life activities.

    The recall will be extended from seven days to four weeks.

Secondary outcomes

  1. Goal Attaiment Scaling

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    The Goal Attainment Scale (GAS) (Turner-Stokes L., 2009) will be used to ascertain the intervention's impact on the vocational goals.

    Participants will be asked to evaluate whether or not they met the intervention goals using a 5-point scale from -2 (goal not met, much worse than expected) to +2 (goal met, much more than expected). A GAS T score will be calculated using the standardised formula for goal attainment. Goals are considered met if the GAS T score is >50.

  2. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    Change in the level of depression symptoms. Higher scores indicate a worse outcome, total scores range from 0-27, scale values range from 0-3.

  3. Generalised Anxiety Disorder - 7 (GAD-7)

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    Change in the level of anxiety symptoms. Higher scores indicate a worse outcome, total scores range from 0-21, scale values range from 0-3.

  4. Perceived Difficulties Questionnaire

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    The Perceived Deficits Questionnaire (PDQ) (Sullivan et al. 1990) explores the perceived cognitive difficulties and measures four sub-scales within the questionnaire: attention/concentration, planning/organisation, retrospective memory and prospective memory.

    The PDQ is a 20-item scale scored with a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The total score for the scale ranges between 0- 80 points, and the domain sub-scales range from 0-20; where a higher score represents a greater perceived cognitive deficits. There is no cut-off score for the sub-scales, but a score of ≥40 on the PDQ is considered as being in a "risk range".

  5. Health-related quality of life

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    EQ-5D-5L - Five scaled questions assess five domains of quality of life (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each response corresponds to a 1-digit number. The total responses are combined into a 5-digit number to represent the health state; e.g., 11111 represents no problems in the health state. These are then converted to an index score; higher scores indicate greater health-related quality of life.

  6. Fatigue levels

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    Modified Impact Fatigue Scale - 5 items (MFIS-5) (Fisk et al., 1994; Fischer et al., 1999). Total score ranges from 0-20; higher scores indicate greater impact of fatigue.

    Scale scores range from 0-4 with 5 scaled questions.

  7. Self-efficacy

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    The Generalised Self-Efficacy Scale (GSE) assesses the participants' belief in their ability to complete tasks successfully. This scale has high internal consistency with alphas are between .76 and .90). The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

  8. Reasonable Adjustments

    Time frame: At baseline, and -6, -9 and 12-months post-randomisation.

    Questions regarding whether the employer has provided or not reasonable adjustments to the employee in the workplace.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Optimising Access to Vocational Rehabilitation Through Multiple Sclerosis Charities: A Feasibility Randomised Controlled Trial

Acronym: MS_Work_Hub

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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