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Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation (MS-Proactive)

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ClinicalTrials.gov Identifier: NCT04515355
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Study Description
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Brief Summary:

About 60-70% of people with multiple sclerosis (PwMS) lose employment within 10 years of the diagnosis. This can be due to complex personal and work-based factors including psychological factors. MS-PROACTIVE aims to test an online self-help therapy to support PwMS to stay in work called 'READY for MS'. This is a type of Acceptance and Commitment therapy. It is a way to provide treatment in a flexible way without people having to go to see a psychologist.

The aim of the treatment is to improve self-efficacy which has been shown to be a significant factor for helping PwMS who want to work to stay in work.

The research team will initially develop an online version of READY for MS. We will ask 4 PwMS to test the online'READY for MS' and provide feedback and advice on any necessary changes. We will then recruit and randomise 88 PwMS in Leeds and London who are at risk of job loss. Participants in the active treatment group will use the online treatment in addition to their usual care; the control group will receive their usual care. The participants will complete questionnaires at the start of the study, at 8 weeks and 6 months measuring time off work and work instability (to measure risk of job loss), self-efficacy, mood, quality of life, fatigue and the impact of MS. The questionnaire data will be analysed to test the effectiveness of the treatment. The research team will also interview 4 PwMS at each site at the start of the study, at 8 weeks and 6 months to find out about their experience of using READY for MS in more detail. This will help to inform the use of READY for MS in a larger trial in the future.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Ready for MS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: People with MS (PwMS)
People with MS recruited to take part and will be randomised to receive the intervention of online programme of support.
 Behavioral: Ready for MS
Receive 'ready for MS' programme in addition to standard care.
No Intervention: People with MS (PwMS) - standard care
People with MS recruited to take part and will be randomised to receive the usual standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Completing the Ready for MS programme [ Time Frame: 7 weeks ]
    Ready for MS is an online programme of support and participants will comple 7 thirty minute online support sessions over 7 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Employed people with a confirmed diagnosis of multiple sclerosis. Paid employment including full-time or part-time work and self-employed. Age 18 years and over Access to a computer or tablet for the on-line sessions. Ability to complete questionnaires at three time points.

Exclusion Criteria:

  • Unpaid employment eg voluntary work. PwMS who are planning to retire or fully leave employment in the time period of the RCT. On sick leave or maternity leave at the time of recruitment.

Significant cognitive impairment.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515355


Contacts
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Contact: Helen Ford, MBChB, MD, FRCP 0113 2433144 helen.ford17@nhs.uk

Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
More Information
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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04515355    
Other Study ID Numbers: NE20/130005
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases