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Assessing NHS ImplemeNTation of an onlinE Resilience Training Acceptance and Commitment Therapy (ACT) Programme to Prevent Job Loss in Multiple Sclerosis

Sponsor: The Leeds Teaching Hospitals NHS Trust

NCT ID: NCT06728956

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
READY for MS UK digital programme (other)
How long the study runs
Study runs about 37 months (dates as stated)
About the drug or intervention
READY for MS UK digital programme — other: Online self-directed programme supported by HCPs
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 66 Years
Who
All
Number of participants
300
Started
2024-06-14
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple sclerosis
  • • NA - 300 participants
  • • People with MS (PwMS) are at increased risk of leaving work earlier than expected

Who can take part?

  • • Ages 18 Years to 66 Years
  • • Diagnosed with multiple sclerosis

Where?

  • • Leeds - Leeds Teaching Hospitals NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

People with MS (PwMS) are at increased risk of leaving work earlier than expected. Psychological factors that affect PwMS may make it more difficult to manage staying in work. These can include psychological flexibility and self efficacy. Psychological flexibility is the ability to effectively manage unwanted inner experiences (e.g., thoughts, memories, bodily sensations) in the present. Self-efficacy is the self-belief that an individual has in their ability to succeed.

More detail

Acceptance and Commitment Therapy (ACT) may help improve psychological flexibility and self-efficacy. Researchers and PwMS at Leeds have recently co-developed an online ACT-type programme called 'READY for MS'. This online programme may be helpful for PwMS who want to stay in work. READY for MS can be used on a computer or mobile device and does not need time off work traveling to see a psychologist. The aim is to understand the feasibility and effectiveness of training MS healthcare professionals to support delivery of the READY programme. Also to understand the long-term outcomes for both healthcare professionals and the PwMS they are supporting. What contexts contribute to effective delivery of the READY for MS programme will be explored. The aim is to test this READY for MS programme in various NHS settings to ensure that the programme is delivering the outcomes expected. This is a concept referred to as 'Intervention fidelity'. The key outcome that will be measured for PwMS is work instability (i.e. risk of job loss). Participants will be invited to complete online questionnaires. These will be completed at baseline, post-intervention and 6 month follow-up. The study team will invite a sub-set of participants to complete semi-structured interviews. The study team will use regular rapid qualitative analysis methods (lightning reports) to assess implementation.

Multiple Sclerosis

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 66 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants capable of giving agreement to take part
  • ✓Age 18 years or above
  • ✓Currently in paid employment with an intention to remain in employment for at least 6 months
  • ✓Phase 2: A registered healthcare professional or allied health professional who works in direct contact with...
  • ✓Phase 3: An individual with a clinical diagnosis of Multiple Sclerosis and reporting a WI score ≥11/22 (on MS-WIS)

Who cannot take part

  • ✗Individuals lacking capacity to give agreement to take part
  • ✗Individuals intending to leave paid employment within the next 6 months
  • ✗Individuals who will not have access to a device used to access the internet (e.g.
  • ✗laptop or smartphone) for the duration of study participation
See the full criteria
Inclusion Criteria: * Participants capable of giving informed consent * Age 18 years or above * Currently in paid employment with an intention to remain in employment for at least 6 months * Phase 2: A registered healthcare professional or allied health professional who works in direct contact with patients diagnosed with Multiple Sclerosis OR * Phase 3: An individual with a clinical diagnosis of Multiple Sclerosis and reporting a WI score ≥11/22 (on MS-WIS) Exclusion Criteria: * Individuals lacking capacity to give informed consent * Individuals intending to leave paid employment within the next 6 months * Individuals who will not have access to a device used to access the internet (e.g. laptop or smartphone) for the duration of study participation

Where Is This Study? (1 UK site)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Recruiting
Data sourced from ClinicalTrials.gov · Last verified: 2024-12