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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ready for MS
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

People with MS (PwMS)

People with MS (PwMS) - standard care

Arm Description

People with MS recruited to take part and will be randomised to receive the intervention of online programme of support.

People with MS recruited to take part and will be randomised to receive the usual standard of care.

Outcomes

Primary Outcome Measures

Completing the Ready for MS programme
Ready for MS is an online programme of support and participants will comple 7 thirty minute online support sessions over 7 weeks

Secondary Outcome Measures

Full Information

First Posted
August 13, 2020
Last Updated
August 13, 2020
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04515355
Brief Title
Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation
Acronym
MS-Proactive
Official Title
Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
People with MS (PwMS)
Arm Type
Experimental
Arm Description
People with MS recruited to take part and will be randomised to receive the intervention of online programme of support.
Arm Title
People with MS (PwMS) - standard care
Arm Type
No Intervention
Arm Description
People with MS recruited to take part and will be randomised to receive the usual standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Ready for MS
Intervention Description
Receive 'ready for MS' programme in addition to standard care.
Primary Outcome Measure Information:
Title
Completing the Ready for MS programme
Description
Ready for MS is an online programme of support and participants will comple 7 thirty minute online support sessions over 7 weeks
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Ford, MBChB, MD, FRCP
Phone
0113 2433144
Email
helen.ford17@nhs.uk
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation

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