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

NCT06728956 | Recruiting

• 1 other identifier: NE24/164889
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  6 months

Study Arms (1)

main

OTHER

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

Interventions

READY for MS UK digital programme OTHER

Online self-directed programme supported by HCPs

main

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: December 11, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)