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

December 6, 2024 updated by: The Leeds Teaching Hospitals NHS Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: main

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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).
6 months
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).
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE24/164889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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