Understanding how an online resilience-training programme can be utilised across NHS settings to support people with multiple sclerosis to stay in work
| ISRCTN | ISRCTN16557392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16557392 |
| IRAS number | 338801 |
| Secondary identifying numbers | CPMS 61223, IRAS 338801 |
- Submission date
- 17/06/2024
- Registration date
- 27/06/2024
- Last edited
- 31/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
People with MS (PwMS) are disproportionately leaving work early. Previous research has shown that psychological factors, such as self-efficacy, play a key role in this. However, in the UK, psychological services are under significant strain with 1.6 million people reported to be on NHS waiting lists for specialised mental health support. A digital resilience-training programme called ‘READY’ has been co-developed in the UK and piloted with PwMS who report work instability. It is important to assess that the digital UK READY programme can be delivered and received as intended; this is known as intervention fidelity. Specifically, this study aims to monitor fidelity to function, i.e. measuring the core functions of the READY programme, through psychological self-report measures. This is important for checking (validating) the use of READY in a “real world” setting. To do this, the researchers will train MS healthcare professionals to support the delivery of READY and then check whether it has been delivered and received as intended. They will also check that READY leads to the intended long-term outcomes for PwMS who receive it.
This study aims to assess NHS implementation of an online type of Acceptance and Commitment Therapy (ACT) codeveloped with PwMS ‘REsilience and Activities for every DaY for MS’ (READY) resource to support resilience at work for PwMS. This will be delivered through five objectives:
1. The feasibility and effectiveness of training MS health practitioners in several NHS centres to support delivery of the digital READY programme to PwMS following an immersive training programme.
2. The effectiveness of delivering the READY programme in the NHS for PwMS when supported by trained MS practitioners and the long-term outcomes
3. Which/how contexts influence how MS practitioners support/engage with PwMS completing the READY programme?
4. Which/how contexts influence how PwMS engage with the READY programme and the long-term outcomes
5. To what extent intervention fidelity mediates these long-term outcomes
Who can participate?
Registered healthcare professionals or allied health professionals who work in direct contact with patients diagnosed with Multiple Sclerosis OR individuals aged 18 years or above with a clinical diagnosis of multiple sclerosis and an intention to remain in work for at least 6 months.
What does the study involve?
All participants will be invited to complete the READY programme. The programme involves completing 7 online sessions delivered over 7 weeks and a further refresher session at 12 weeks. There is also a workbook to help with the online sessions. The whole-time commitment for all participation activities in this study is about 8 hours in total. This includes completing the READY programme modules and any questionnaires. Participants will be asked to complete questionnaires at the beginning of the study (baseline) and at 8 weeks and 6 months. A small subset of participants will also be invited to take part in research interviews to understand their experiences with using the READY programme.
What are the possible benefits and risks of participating?
For health professionals, the possible benefit of taking part is that the READY programme has been shown to lead to personal and professional benefits for health professionals. ACT interventions have also been shown to protect against burnout.
For people with MS, the possible benefit of taking part is that the READY programme has been shown to help people with MS with ‘bouncing back’ (resilience) in the context of adversity. It aims to equip PwMS with skills to manage real-world stressors.
Training health professionals to support the UK digital READY programme may improve access to psychological interventions for PwMS who would benefit from them. MS nurses, occupational therapists, and physiotherapists may also be able to offer more personalised support as part of the digital READY programme.
There is an unmet need for timely interventions with a focus on keeping PwMS in work. Effective interventions need to be flexible and easily accessible for employed people. If this implementation trial is successful then the online READY may be made more widely available for PwMS to use.
All of the participants in the trial will receive a full report on the outcomes of the study.
In terms of risks, some people can find completing questionnaires stressful and can make them think about negative aspects of their psychological wellbeing. The READY programme may highlight thoughts and feelings that are uncomfortable or difficult to deal with. ACT-style therapy is designed to help you learn to cope with these difficult thoughts and feelings rather than avoid them, therefore, it is important to keep practising the strategies and exercises in the READY programme for this to work.
Where is the study run from?
Leeds Teaching Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2022 to December 2026
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Dr Charli R Wicks, charlotte.wicks1@nhs.net
Contact information
Public, Scientific, Principal Investigator
Neurology Research Office
D Floor, Martin Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0002-4769-2249 |
|---|---|
| Phone | +44 (0)113 3923468 |
| leedsth-tr.interactms@nhs.net |
Study information
| Study design | Non-randomized; Both; Design type: Treatment, Prevention, Psychological & Behavioural, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 45633_PIS_HCP_V1_18Apr24.pdf |
| Scientific title | Assessing NHS ImplemeNTation of an onlinE Resilience-training Acceptance and Commitment Therapy programme to prevent job loss in Multiple Sclerosis |
| Study acronym | INTERACT-MS |
| Study objectives | The researchers expect that this Acceptance and Commitment Therapy (ACT)-based programme should lead to increased resilience, psychological flexibility, and self-efficacy. They theorise that increasing these psychological factors should lead to a reduction in work instability. This should mean there is a significant reduction in work instability in participants who complete the digital READY for MS programme. |
| Ethics approval(s) | Approved 08/05/2024, North of Scotland Research Ethics Committee 2 (North of Scotland Research Ethics Service, Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224558458; gram.nosres@nhs.scot), ref: 24/NS/0041 |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | This is a multi-phase hybrid effectiveness-implementation study to test the effectiveness of the READY for MS intervention when NHS healthcare professionals are trained to support it for people with multiple sclerosis (PwMS). The first phase will be to train the healthcare professionals (HCPs) in supporting the programme. This involves HCPs completing the READY for MS programme and then completing a training workshop to understand the core principles of Acceptance and Commitment Therapy. During programme completion, HCPs will receive support from a trained psychologist. The psychologist will audio-record these support calls to capture and assess troubleshooting topics that arise. The researchers will invite HCPs to complete questionnaires at baseline (i.e. before doing the READY programme), week 8 (post-intervention) and month 6. Questionnaires will collect information on demographics and work details, a general health rating and include validated scales to measure resilience, psychological flexibility, and system usability. Following the training workshop, HCPs will be asked to complete an ACT-competencies questionnaire and provide qualitative feedback on their experience of the training and any anticipated barriers to supporting others to complete the programme. A small subset of HCPs will be invited to take part in semi-structured interviews which will be conducted after completing the programme to understand their experiences with the programme and expectations around supporting PwMS. The second phase will recruit PwMS and invite them to complete the READY for MS programme supported by a HCP at their relevant NHS site. PwMS will be invited to complete questionnaires at baseline, week 8 and month 6. Questionnaires will collect information on demographics and work details, a general health rating and include validated scales to measure work instability, resilience, psychological flexibility, self-efficacy, mood, impact of MS, and system usability. A small subset of PwMS will be invited to take part in semi-structured interviews post-intervention and at 6-month follow-up. All participants (HCPs and PwMS) from ≥2 weeks since baseline will be invited to complete an optional pulse free-text survey which will contribute to lightning reports. These surveys will take less than 10 minutes to complete. Participants will have the option to complete unstructured tele-interviews as part of these pulse surveys if they would like to discuss their feedback further. |
| Intervention type | Behavioural |
| Primary outcome measure | PwMS phase: 1. Work instability is measured using the Multiple Sclerosis work instability scale at baseline, week 8, and month 6 2. Resilience is measured using the Connor-Davidson Resilience Scale at baseline, week 8, and month 6 3. Psychological flexibility is measured using the Multi-dimensional psychological flexibility inventory at baseline, week 8, and month 6 4. Self-efficacy is measured using the unidimensional self-efficacy scale at baseline, week 8, and month 6 |
| Secondary outcome measures | HCP phase: 1. Resilience is measured using the Connor-Davidson Resilience Scale at baseline, week 8, and month 6 2. Psychological flexibility is measured using the Multi-dimensional psychological flexibility inventory at baseline, week 8, and month 6 3. System useability is measured using the system useability scale at week 8 and month 6 4. ACT-based competencies are measured using the ACT knowledge questionnaire at week 8 PwMS phase: 1. Overall health is measured using a general health visual analogue scale at baseline, week 8, and month 6 2. Mood (anxiety, depression) is measured using the Hospital anxiety and depression scale at baseline, week 8, and month 6 3. Impact of MS is measured using the Multiple Sclerosis Impact scale at baseline, week 8, and month 6 4. System useability is measured using the system useability scale at week 8 and month 6 |
| Overall study start date | 01/04/2022 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Key inclusion criteria | 1. Participants capable of giving informed consent 2. Aged 18 years or above 3. 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 Phase 3: An individual with a clinical diagnosis of Multiple Sclerosis and reporting a WI score >= 11/22 (on MS-WIS) |
| Key exclusion criteria | 1. Individuals lacking the capacity to give informed consent 2. Individuals intending to leave paid employment within the next 6 months 3. 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 |
| Date of first enrolment | 14/06/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Cardiff
CF14 4XW
United Kingdom
WC1N 3BG
United Kingdom
Mile End Road
London
E1 4NS
United Kingdom
Leeds
LS1 3EX
United Kingdom
Leeds
LS14 6UH
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Harton Lane
South Shields
NE34 0PL
United Kingdom
Sponsor information
Hospital/treatment centre
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
England
United Kingdom
| Phone | +44 (0)1132060460 |
|---|---|
| sarah.hall50@nhs.net | |
| Website | http://www.leedsth.nhs.uk/home/ |
"ROR" |
https://ror.org/00v4dac24 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Dissemination to the scientific community will be made via conference abstracts and submissions to high-impact peer-reviewed journals so that other researchers and healthcare professionals can bring these findings to their own practices. The researchers intend to publish these key findings by the end of 2027 with interim analyses disseminated at conferences throughout the course of the trial. Key findings will also be shared via MS charity public forums including the MS society and shift.ms by the end of 2027 so that people affected by MS can benefit from insights and increased awareness of potential new interventions. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Charli Wicks (charlotte.wicks1@nhs.net). The Trial Monitoring Group will review formal requests for access to the final dataset. Participant consent to share anonymised data for the purposes of future research will be obtained. The full dataset will be available on completion of the study and research data will be retained for 5 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Healthcare professionals version 1 |
18/04/2024 | 18/06/2024 | No | Yes |
| Participant information sheet | People with MS version 1 |
18/04/2024 | 18/06/2024 | No | Yes |
| Protocol file | version 1 | 26/03/2024 | 18/06/2024 | No | No |
Additional files
- 45633_PROTOCOL_V1_26Mar24.pdf
- 45633_PIS_HCP_V1_18Apr24.pdf
- Healthcare professionals
- 45633_PIS_PwMS_V1_18Apr24.pdf
- People with MS
Editorial Notes
31/01/2025: The following changes were made to the trial record:
1. The contact email was changed.
2. The study participating centres Northumbria Healthcare NHS Foundation Trust, South Tyneside NHS Foundation Trust were added.
17/06/2024: Study's existence confirmed by the NIHR.
