Multiple SclerosisINTERACT-MSNCT06728956
Assessing NHS ImplemeNTation of an onlinE Resilience Training Acceptance and Commitment Therapy (ACT) Programme to Prevent Job Loss in Multiple Sclerosis
A study testing READY for MS UK digital programme in people with Multiple Sclerosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- READY for MS UK digital programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Charlotte DR Wicks, 01132060483, Charlotte.wicks1@nhs.ne
leedsth-tr.researchgovernance@nhs.net
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- READY for MS UK digital programme
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
READY for MS UK digital programmeOther
Online self-directed programme supported by HCPs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: READY for MS UK digital programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start14 Jun 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728956
- Sponsor's protocol ID
- NE24/164889
- Acronym
- INTERACT-MS
- Status last verified
- Dec 2024
- First submitted
- 6 Aug 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing NHS ImplemeNTation of an onlinE Resilience Training Acceptance and Commitment Therapy (ACT) Programme to Prevent Job Loss in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06728956
- Acronym / sponsor ID
- INTERACT-MS / NE24/164889
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main | Other | Other: READY for MS UK digital programmeParticipant 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. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| READY for MS UK digital programmeOnline self-directed programme supported by HCPs | Other | main |
Primary outcome
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing READY for MS UK digital programme in people with Multiple Sclerosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Work Instability Scale (MS-WIS) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.