Development of an online, group-based, clinical neuropsychology rehabilitation programme
| ISRCTN | ISRCTN13391549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13391549 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 316145 |
| Protocol serial number | CPMS 55258, NIHR202753, IRAS 316145 |
| Sponsor | University of Nottingham |
| Funder | NIHR Central Commissioning Facility (CCF) |
- Submission date
- 30/08/2023
- Registration date
- 15/09/2023
- Last edited
- 02/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Acquired brain injury (ABI) is caused by medical conditions (e.g., stroke) or injuries (e.g., traffic accidents). In the UK, 1.4 million people live with the consequences of ABI, which can be lifelong, costing the economy £15 billion annually (10% NHS annual budget). Approximately 20% of ABI survivors experience emotional and/or thinking skills problems. These can impact return to hobbies and work, increasing risk of isolation and resulting in distress and reduced quality of life. Neuropsychological rehabilitation is useful in treating such problems but is typically delivered face-to-face. However, due to the lack of NHS resources, not all ABI survivors get thee help they need. Furthermore, limited clinic space and other restrictions mean group sessions cannot always be provided safely, if at all.
The study aims to test whether people with ABI find a newly developed online, group-based neuropsychological rehabilitation programme useful and acceptable.
Who can participate?
Adults who have experienced an acquired brain injury and left hospital at least three months prior to the study commencing.
What does the study involve?
To test the intervention participants will:
1. Complete questionnaires at the start of the study
2. Take part in a session to find out more about their presenting strengths and challenges and adjustments that could be helpful with the Clinical Neuropsychologist
3. Take part in 8 weekly, online, group sessions
4. Complete questionnaires at the end of the study, and provide feedback in an interview with a researcher
What are the possible risks and benefits of participating?
The risk of serious harmful effect due to participating in the study is considered low. Participants will be completing questionnaires and talking about topics, and they may experience some distress if they find they are not performing as well as they think and/or if sensitive topics are raised. To minimise risk all members of the research team will be trained to identify and respond to signs of distress in a sensitive manner, and a risk protocol will be in place.
Whilst there is no guarantee of benefit, the neuropsychological rehabilitation programme could potentially improve participants' emotional wellbeing, quality of life, and ability to 'live well' with ABI by offering education and strategies.
Where is the study run from?
The study is run from the University of Nottingham, in collaboration with Nottinghamshire Healthcare NHS Trust and Midlands Partnerships University NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
March 2022 to March 2024
Who is funding the study?
This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR202753).
Who is the main contact?
Kim Fletcher, kimberley.fletcher@nottingham.ac.uk
Contact information
Scientific
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
| Phone | +44 1159 515151 |
|---|---|
| Kimberley.fletcher@nottingham.ac.uk |
Scientific
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
| Phone | +44 1159 515151 |
|---|---|
| roshan.dasnair@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Development and refinement of an online, group-based, clinical neuropsychology rehabilitation programme to improve psychological well-being and quality of life after acquired brain injury |
| Study acronym | NeRO Work Package 3 |
| Study objectives | To examine preliminary acceptability and fidelity of a new, online, group-based, clinical neuropsychology rehabilitation programme. To determine (preliminary) promise of the intervention. |
| Ethics approval(s) |
Approved 23/03/2023, London Harrow (Level 3, Block B, Whitefriars, Bristol, BS1 2NT, United Kingdom; +44 207 104 8154; harrow.rec@hra.nhs.uk), ref: 23/LO/0149 |
| Health condition(s) or problem(s) studied | Acquired brain injury |
| Intervention | Baseline assessment All participants at the baseline stage will complete questionnaires online with the study Research Support Fellow. Questionnaires will assess well-being, mood, anxiety, suicide risk, acceptance, compassion, living towards values, self-perceived cognitive deficits and quality of life. If thought to be eligible for the study, the research support fellow will also check availability to attend intervention sessions and schedule an initial individual session with the clinical neuropsychologist. Clinical Neuropsychology session Once baseline measures have been completed, and the participant is determined as eligible to take part, the participant will meet with the clinical neuropsychologist to complete an initial formulation session. This will develop an understanding of the participants presenting challenges and strengths, and consider helpful adaptations. Eligibility criteria will also be reconsidered at this stage. Neuropsychological rehabilitation The intervention group will involve weekly online group-based neuropsychological rehabilitation (NPR) sessions for 8 consecutive weeks. The sessions will last approximately 1 hour each and will involve two groups with 4-6 participants each. All intervention sessions, screening assessments and outcome assessments will be conducted online via MS Teams video conferencing or alternative HS Compliant platform. All participants will be given instructions on how to use MS Teams (or alternative) if needed. Outcome assessment The outcome assessment will take place 2- weeks after intervention completion. This will be completed online directly with the participants. The participant will complete a change and feedback interview, and complete outcome measures. Assessments will be completed by the research support fellow who will not be involved in delivering the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Mood/Depression measured using Patient Health Questionnaire 9 at baseline, and 2-weeks post intervention completion. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 11 |
| Key inclusion criteria | 1. Acquired brain injury experienced as an adult (>18 years), at least three-months prior to joining the study 2. Age >18 years 3. Self-reported sense of being ‘stuck’ and/or emotional difficulties related to ABI rehabilitation (screened during initial interview) 4. English-speaking 5. Able to access the online platform 6. Ability to give informed consent and complete outcome measures |
| Key exclusion criteria | 1. Pre-existing intellectual disability 2. Severe psychiatric disorder (at time of screening or in previous year), and/or factors (e.g., suicidal intent or ideation) indicating alternative treatment may take priority 3. Comorbid neurodegenerative condition 4. Indication that group intervention may not be appropriate (screened during baseline and initial interview) |
| Date of first enrolment | 30/05/2023 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Bridge Park Plaza
Bridge Park Road
Leicester
LE4 8PQ
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The datasets generated and/or analysed during the current study will be available upon request from Kim Fletcher (kimberley.fletcher@nottingham.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/04/2024: The total final enrolment was added.
20/09/2023: A link to the HRA research summary was added.
30/08/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
