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NCT Number: NCT06728956

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

READY for MS UK digital programme

Other

Online self-directed programme supported by HCPs

Primary outcomes

  1. Multiple Sclerosis Work Instability Scale (MS-WIS)

    Time frame: 6 months

    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).

  2. Psychological Flexibility -Multi-dimensional Psychological Flexibility Inventory (MPFI)

    Time frame: 6 months

    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).

  3. Resilience Connor-Davidson Resilience Scale (CD-RISC 10)

    Time frame: 6 months

    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).

  4. Self-efficacy -Unidimensional Self-efficacy scale for Multiple Sclerosis (USE-MS)

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Acronym: INTERACT-MS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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