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Recruiting NCT06728956

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

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: READY for MS UK digital programme.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 66 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other READY for MS UK digital programme
    Online self-directed programme supported by HCPs

Primary outcome measures

  • Multiple Sclerosis Work Instability Scale (MS-WIS) [Time frame: 6 months]
  • Psychological Flexibility -Multi-dimensional Psychological Flexibility Inventory (MPFI) [Time frame: 6 months]
  • Resilience Connor-Davidson Resilience Scale (CD-RISC 10) [Time frame: 6 months]
  • Self-efficacy -Unidimensional Self-efficacy scale for Multiple Sclerosis (USE-MS) [Time frame: 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United Kingdom · 1 center
  • Leeds Teaching Hospitals NHS Trust — Leeds

Identifiers

NCT: NCT06728956 · NE24/164889

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗