An interventional study of READY for MS UK digital programme in Multiple Sclerosis, sponsored by The Leeds Teaching Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Supportive care
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 300 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
laptop or smartphone) for the duration of study participation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant outcomes will be measured at multiple time points (baseline, week 8 and month 6). assess for any change to outcome variables over time using repeated measures ANOVA, this provides only an overview of interventional impact and assumes homogenous change within the study group. Latent Growth Curve Modelling (LGCM) can be useful to identify patterns within subgroups of a population to understand who benefits from an intervention and why. Latent Growth Curve Modelling (LGCM) will be used to determine trajectories over time. Changes from baseline to week 8 and baseline to month 6 will be assessed.
Other: READY for MS UK digital programme
Online self-directed programme supported by HCPs
Multiple Sclerosis Work Instability Scale (MS-WIS)
A 22-item psychometric validated self-report scale to measure work instability in multiple sclerosis. Work instability refers to any mismatch between job demands and an individual's functional (in)capacity and the extent to which this increases risk of job loss. Scores range from 0-22 and work instability is scored in bands of low risk (0-10), medium risk (11-16) and high risk (17-22).
Time frame: 6 months
Psychological Flexibility -Multi-dimensional Psychological Flexibility Inventory (MPFI)
a 60-item psychometric validated self-report scale to assess the key dimensions of flexibility and inflexibility from the Hexaflex model. For each sub-scale, items are scored 1-6 and then an average taken across the items of the sub-scale so that higher scores reflect higher levels of the dimension being assessed by each set of items. For the flexibility sub-scales, a higher score would indicate greater flexibility (better outcome) and for inflexibility sub-scales, higher scores indicate greater inflexibility (worse outcome).
Time frame: 6 months
Resilience Connor-Davidson Resilience Scale (CD-RISC 10)
A 10-item unidimensional psychometric validated self-report scale to measure resilience. Scores range 0-40 with a higher score indicating greater resilience (better outcome).
Time frame: 6 months
Self-efficacy -Unidimensional Self-efficacy scale for Multiple Sclerosis (USE-MS)
a 12-item psychometric validated self-report scale to measure self-efficacy in Multiple Sclerosis. Scores range 0-36 with a higher score indicating higher self-efficacy (better outcome).
Time frame: 6 months
Plan to share: No
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