Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation

NCT ID: NCT04515355

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

People with MS (PwMS)

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

Group Type EXPERIMENTAL

Ready for MS

Intervention Type BEHAVIORAL

Receive 'ready for MS' programme in addition to standard care.

People with MS (PwMS) - standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ready for MS

Receive 'ready for MS' programme in addition to standard care.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Helen Ford, MBChB, MD, FRCP

Role: CONTACT

0113 2433144

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NE20/130005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.