Delivering inclusive, accessible support for psychological adjustment after stroke
| ISRCTN | ISRCTN17628580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17628580 |
| IRAS number | 287785 |
| Secondary identifying numbers | CPMS 63014, Stroke Association Grant Codes: PG22/23_S1100063, IRAS 287785 |
- Submission date
- 16/08/2024
- Registration date
- 28/11/2024
- Last edited
- 23/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke survivors face a range of challenges in adjusting to life after stroke. There are limited treatment options and a lack of psychologists to provide support. Acceptance and Commitment Therapy (ACT) has successfully improved wellbeing. An earlier study working with stroke survivors, healthcare professionals and researchers developed WAterS (Wellbeing after stroke). WAterS is informed by ACT, designed specifically for groups of stroke survivors for remote delivery. Researchers also developed a training and supervision programme for staff without ACT expertise to deliver WAterS. The findings were promising. Changes are required to make WAterS more inclusive. This study aims to deliver an adapted therapy (WAterS-2), within the NHS, targeting stroke survivors with communication disabilities and those from minoritized ethnic communities. The study will explore:
1. If WAterS-2 can be provided as planned
2. Patient and staff experiences of WAterS-2 in terms of perceived impact, acceptability and safety
3. Factors that may help or hinder future WAterS research
Who can participate?
Stroke survivors aged 18 years and over, at least 4 months after stroke, with self-reported difficulty adjusting.
What does the study involve?
Participants will be invited to attend the WAterS-2 group course that aims to help people adjust after a life-changing stroke event. Each course will consist of eight online group sessions lasting up to 2 hours. More information on the WAterS2 intervention is available on the study website and in published papers. If a participant requires support to take part, a supporting individual will also be recruited and will feedback on the experience. The researchers will use online surveys and feedback questionnaires and will review recordings of sessions to collect information on delivery success and acceptability. Some people will also be invited to an interview with a researcher to understand more about their experiences
What are the possible benefits and risks of participating?
This is provided in the detailed Information Sheet for stroke survivors who are referred to the study team for more information. Please note that recruitment will be managed through participating sites.
Where is the study run from?
The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
October 2023 to December 2025
Who is funding the study?
The Stroke Association (UK)
Who is the main contact?
Dr Emma Patchwood, waters@manchester.ac.uk
Contact information
Scientific
University of Manchester
Stopford Building
Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-4198-5761 |
|---|---|
| Phone | +44 (0)161 2753401 |
| emma.patchwood@manchester.ac.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Prevention, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Wellbeing After Stroke (WAterS-2): Upskilling a workforce to deliver inclusive, accessible psychological support after stroke |
| Study acronym | WAterS-2 |
| Study objectives | In keeping with the aims of this feasibility study, there are no experimental or null hypotheses. The aim is to deliver an adapted therapy (WAterS-2), within the NHS, targeting stroke survivors with communication disabilities and those from minoritized ethnic communities. The researchers will explore: 1. If WAterS-2 can be provided as planned 2. Patient and staff experiences of WAterS-2 in terms of perceived impact, acceptability and safety 3. Factors that may help or hinder future WAterS research |
| Ethics approval(s) | Approved 29/08/2024, Wales REC6 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2922940911, +44 (0)2922 940954, +44 (0)2922 941090; Wales.REC6@wales.nhs.uk), ref: 24/WA/0238 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | This is a pilot study, exploring the feasibility and acceptability of the WAterS2 remote group intervention to support adjustment after stroke. The group intervention is informed by Acceptance and Commitment Therapy (ACT) and delivered remotely to groups over 8 weekly sessions. More details on the intervention are available via the linked study website and published papers. There is no comparator/control group. All research procedures, including data collection, are conducted electronically/online. There are three different 'types' of research participants: 1. Staff: trained and supported to deliver the WAterS-2 intervention 2. Stroke survivors: receive the WAterS-2 intervention 3. 'Supporting individuals' (e.g. family members, carers, friends) who may be recruited to support stroke survivors to participate, if stroke survivors request. To broadly summarise the overall timeline and procedures of the study: 1. Staff are recruited and trained by research team Clinical Psychologists. Training is conducted over 4x half-day sessions. Training sessions are recorded to monitor fidelity (to explore: did we deliver training as planned?). Staff are asked to give feedback on the training received. 2. Stroke survivors (and any requested 'supporting individuals') are recruited, with baseline demographic and clinical data collected. 3. WAterS-2 groups conducted: 8 x weekly remote group sessions, lasting 2 hours per session. Two trained staff facilitate each group session with up to six recruited stroke survivors + any of their recruited supporting individuals. The sessions are primarily aimed at stroke survivors' psychological adjustment. Supporting individuals are, as named, there to support. Group sessions are recorded for monitoring fidelity (to explore: did we deliver the WAterS-2 intervention as planned?). Staff will also be asked to complete checklists after each session to help monitor fidelity. 4. OPTIONAL weekly group clinical supervision for staff running WAterS-2 groups: staff will have access to a weekly group support session, facilitated by research team Clinical Psychologists, to help improve fidelity and provide support for delivery of the group sessions. 5. Once all eight WAterS-2 group sessions are complete, all stroke survivors are asked to complete measures exploring their wellbeing and the impact of groups. Both stroke survivors and any supporting individuals will be asked to give feedback on their experiences through questionnaires. A sub-sample will be invited to give more feedback in qualitative interviews with the research team. Staff will also be asked to complete questionnaires about their experiences of delivering the group sessions. 6. Three months after groups have completed, stroke survivors will be asked to complete a final 'follow-up' of measures exploring their wellbeing and the perceived impact of groups. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary aim of this study is to establish the feasibility and acceptability of the intervention and a future definitive trial. As such most measures will relate to feasibility, collected and summarised by the end of the study period in time for write-up (approx. June 2025), such as: 1. Establishing recruitment pathways and workforce criteria in three test sites 2. Informing the recruitment and retention of a future fully-powered trial by establishing the number of participants identified, approached, consented, randomised and completed. 3. Refining future study procedures by establishing the acceptability and experience of the trial process to participants, including completion of outcome measures. 4. Determining the fidelity of delivery of the intervention through checklists and recordings 5. Determining the optimal primary outcome measure in future work by assessing the performance of selected candidate outcome measures with respect to the level of acceptability to participants (completion rates, perceived burden) and participant-perceived relevance and value. 6. Further assessing the acceptability of the treatment via qualitative interviews and more. |
| Secondary outcome measures | Some examples of measures that will be taken at timepoints are as follows: 1. At baseline: demographic and self-report clinical information related to the impact of impairments to cognition and language. 2. At baseline: research administered remote assessment of cognition and communication (this will be to establish, post hoc, whom this intervention might be best-suited for. It is not used to determine eligibility) In addition, the following Patient Reported Outcome Measures (PROMs) are repeated at baseline, after group intervention is completed, and again 3 months later: 3. Mood as recorded by the Hospital Anxiety and Depression Scale (HADS) 4. Wellbeing as recorded by Office of National Statistics 4 (ONS4) 5. Quality of life as recorded by EQ-5D-5L 6. Adjustment and acceptance as recorded by the Acceptance and Action Questionnaire for Acquired Brain Injury (AAQ-ABI) 7. Valued living as recorded by the Valuing Questionnaire (VQ) 8. Feedback questionnaires and qualitative interviews will also be conducted |
| Overall study start date | 01/10/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | Staff inclusion criteria: 1. Can participate with clearance and support from their line manager 2. An understanding of the impact of stroke 3. Experience/knowledge of facilitating groups 4. Willing to be trained and adhere to research procedures Stroke survivor inclusion criteria: 1. Adults in the UK (at least 18 years old) 2. At least 4 months post-stroke (no upper limit) 3. Who identify as having unmet needs in terms of psychological adjustment to stroke 4. Sufficient English language to engage in groups/complete measures 5. Access to the internet and ability to engage in remote group intervention Supporting individual inclusion criteria: 1. Adults in the UK (over the age of 18 years) 2. Supporting a stroke survivor who is a participant in WAterS-2 3. Sufficient English language to engage in groups/complete measures 4. Capacity to consent |
| Key exclusion criteria | Staff exclusion criteria: 1. Not meeting the above inclusion criteria Stroke survivor exclusion criteria: 1. Lacking the capacity to consent 2. Stroke survivors who identify as severely anxious or depressed, or at risk of harm would be excluded from this research, and information on referral to appropriate expert psychological support will be provided Supporting Individual exclusion criteria: 1. Not meeting the above inclusion criteria |
| Date of first enrolment | 05/12/2024 |
| Date of final enrolment | 01/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PT
United Kingdom
Sponsor information
Hospital/treatment centre
Faculty of Biology, Medicine and Health
Room 4.64 Simon Building
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 5318 |
|---|---|
| fbmhethics@manchester.ac.uk | |
| Website | https://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | An easy-read report will be made available on the study website by December 2025: https://sites.manchester.ac.uk/waters2/. The Patient Carer Public Involvement (PCPI) Research Advisory Panel (RAP) will advise on additional, accessible means of communicating research findings with stroke patients e.g. adding a video to the study YouTube channel (https://www.youtube.com/@watersstudy). The researchers also plan to publish in a high-impact peer-reviewed journal by the end of 2025 / beginning of 2026. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
23/05/2025: Total final enrolment added. The overall study end date was changed from 30/09/2025 to 31/12/2025.
16/08/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
