A study exploring whether clinical hypnosis is helpful and acceptable for people with functional neurological disorder (FND)
| ISRCTN | ISRCTN59168898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59168898 |
| Integrated Research Application System (IRAS) | 361289 |
| Sponsor | Lancashire Teaching Hospitals NHS Foundation Trust |
| Funder | Lancashire Teaching Hospitals NHS Foundation Trust |
- Submission date
- 16/09/2026
- Registration date
- 03/10/2026
- Last edited
- 17/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Functional Neurological Disorder (FND) is a condition that causes symptoms such as seizures, movement problems, weakness, sensory changes, and other neurological symptoms that cannot be explained by structural disease of the nervous system. Clinical hypnosis is already offered as part of routine care in the specialist FND service at Royal Preston Hospital, but more research is needed to understand how helpful and acceptable it is for people with FND.
This study aims to explore whether clinical hypnosis may improve symptoms, psychological wellbeing, daily functioning, and quality of life for people with FND. It will also examine participants' experiences of receiving hypnosis and gather suggestions for improving this type of treatment.
Who can participate?
Adults aged 18 years or older with a confirmed diagnosis of FND who are patients of, or have been referred to, the specialist FND service at Royal Preston Hospital may be eligible to take part. Participants must be able to give informed consent and complete the study questionnaires in English.
What does the study involve?
Participants who agree to take part will first complete an online questionnaire before starting their course of clinical hypnosis. They will then receive three face-to-face hypnosis sessions as part of their usual NHS care. These sessions take place every 2 weeks over approximately 6 weeks and each session lasts about 45 to 60 minutes.
Participants will complete a second online questionnaire after their third hypnosis session and a final questionnaire 4 weeks later. Each questionnaire takes around 20 minutes to complete.
Some participants will also be invited to take part in a one-to-one interview about their experiences of hypnosis. The interview is optional, lasts around 30 to 60 minutes, and can take place by telephone or Microsoft Teams. Overall, participants will be involved in the study for approximately 10 weeks.
What are the possible benefits and risks of participating?
Participants may not receive any direct benefit from taking part. However, some people with FND have found hypnosis helpful for managing symptoms, and participants may value contributing to research that could help improve care for others with FND in the future.
Clinical hypnosis is generally considered a low-risk intervention. Some people may temporarily feel tired, light-headed, emotional, or more aware of bodily sensations. Occasionally, symptoms may briefly worsen. Some questionnaire or interview questions may also bring up difficult thoughts or feelings. Participants can pause or stop any part of the study at any time without affecting their usual care.
Where is the study run from?
The study is being run through the specialist FND service at Royal Preston Hospital, part of Lancashire Teaching Hospitals NHS Foundation Trust, in collaboration with Lancaster University.
When is the study starting and how long is it expected to run for?
September 2026 to June 2027.
Who is funding the study?
The study is funded by Lancashire Teaching Hospitals NHS Foundation Trust (UK).
Who is the main contact?
Chief investigator: Dr Daniela Di Basilio Lancaster University, d.dibasilio@lancaster.ac.uk
Principal investigator: Dr Abhijit Das Royal Preston Hospital, abhijit.das@lthtr.nhs.uk
Contact information
Principal investigator
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
 ORCID ID |
0000-0001-8800-8047 |
|---|---|
| Phone | +44 1772523896 |
| abhijit.das@lthtr.nhs.uk |
Scientific, Public
Clinical Psychology
Health Innovation One
Sir John Fisher Drive
Lancaster University
Lancaster
LA1 4AT
United Kingdom
| Phone | +44 1772523895 |
|---|---|
| d.dibasilio@lancaster.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Prospective, longitudinal, mixed-methods observational cohort study |
| Participant information sheet | 50304 PIS_Stage Two (Interviews)_v1.1_01May26.pdf |
| Scientific title | Clinical hypnosis for functional neurological disorder: a mixed-methods feasibility study of outcomes and acceptability |
| Study objectives | Overall aim: To preliminarily evaluate the effectiveness, feasibility, and usability of clinical hypnosis as a treatment for individuals diagnosed with Functional Neurological Disorder (FND), using a mixed-methods design. Quantitative objectives: The quantitative component of the study will specifically aim to: 1. Assess psychological well-being: Determine the impact of clinical hypnosis on key indicators of psychological well-being, namely levels of anxiety, depression, stress, and health-related quality of life, at three time points: baseline, after a course of three fortnightly sessions (6 weeks in total), and at follow-up (4 weeks post-treatment) 2. Measure changes in functional symptoms:Evaluate whether there are differences in functional neurological symptoms (e.g. functional seizures, motor disturbances) by comparing symptom frequency and severity at baseline, after 6 weeks of clinical hypnosis, and at follow-up 3. Examine the sustainability of treatment effects: Investigate the persistence of any therapeutic benefits by assessing whether improvements in psychological well-being, quality of life, and symptom severity are maintained at follow-up Qualitative objectives: 1. Explore participants' experiences of receiving clinical hypnosis, including any perceived benefits and barriers to engagement 2. Understand how participants interpret any observed changes in symptoms or well-being in the context of their broader lived experience with FND 3. Identify service users' recommendations for improving the delivery and accessibility of hypnosis-based interventions for the FND population |
| Ethics approval(s) |
Approved 11/05/2026, HRA Proportionate Review Service (2nd Floor, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 20 7104 8260; approvals@hra.nhs.uk), ref: 26/PR/0366 |
| Health condition(s) or problem(s) studied | Functional Neurological Disorder (FND) |
| Methodology | Participants with a confirmed diagnosis of Functional Neurological Disorder (FND) who are receiving, or are due to receive, clinical hypnosis as part of routine care at the Royal Preston Hospital FND service will be invited to take part. After reviewing the participant information sheet and providing electronic informed consent through REDCap, participants will complete baseline questionnaires before their first hypnosis session (T1). Participants will then receive three face-to-face clinical hypnosis sessions delivered fortnightly over approximately 6 weeks, with each session lasting around 45 to 60 minutes. At the end of the third session (T2), participants will complete a second set of questionnaires assessing symptoms, well-being, functioning, and treatment experiences. Four weeks after T2, participants will be contacted to complete a final follow-up questionnaire (T3). Information on any additional hypnosis sessions received during the follow-up period will also be recorded. A subset of approximately 10 to 15 participants who have consented to the qualitative component may also be invited to take part in a single semi-structured interview lasting approximately 30 to 60 minutes, conducted by telephone or Microsoft Teams, to discuss their experiences of clinical hypnosis. Total duration of observation: approximately 10 weeks (baseline to 4-week follow-up) Total duration of follow-up: 4 weeks (from post-treatment assessment at T2 to follow-up assessment at T3) |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Diagnosis: Confirmed diagnosis of FND by a neurologist or specialist in the FND service (e.g. motor or sensory functional symptoms) 2. Age: Adults aged 18 years or above 3. Location of care: Currently a patient at the FND service (Lancashire Teaching Hospitals) or referred to this service for treatment 4. Consent capacity: Capable of giving informed consent to participate, and able to comply with study procedures (e.g. completing questionnaires and attending or participating in therapy sessions) 5. Language: Sufficient proficiency in English to understand the Participant Information Sheet (PIS), give consent, and engage in therapy and interview (as all materials and sessions will be conducted in English) |
| Key exclusion criteria | 1. Serious comorbid conditions: Presence of severe unmanaged physical or mental health conditions that would interfere with participation. For example, an active severe neurological disease other than FND, or severe psychiatric disorders (such as psychosis or significant cognitive impairment) that impair the ability to engage in hypnotherapy or complete questionnaires. These could confound results or pose safety/consent issues 2. Inability to consent or communicate: Individuals who lack capacity to give informed consent or who cannot participate in research activities due to communication barriers (e.g. non-English speakers without available translation, or those with severe language or cognitive barriers) will be excluded 3. Concurrent participation in conflicting research: Participants enrolled in another interventional clinical trial or research study that could conflict with this intervention’s outcomes will be excluded, to avoid confounding effects 4. Declines hypnotherapy: Patients who, after discussion and/or after trying an initial session of hypnotherapy, are unwilling to undergo hypnotherapy treatment would not be suitable, since the intervention is central to the study |
| Date of first enrolment | 17/09/2026 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Consent Form Stage One (Survey) version 1.0 |
23/02/2026 | 17/09/2026 | No | No |
| Other files | Consent Form Stage Two (Interview) version 1.0 |
23/02/2026 | 17/09/2026 | No | No |
| Participant information sheet | Stage One Evaluation of Intervention (Survey) version 1.1 |
01/05/2026 | 17/09/2026 | No | Yes |
| Participant information sheet | Stage Two (Interviews) version 1.1 |
01/05/2026 | 17/09/2026 | No | Yes |
| Protocol file | version 1.0 | 27/03/2026 | 17/09/2026 | No | No |
Additional files
- 50304 Study Protocol_FND and Hypnotherapy_Mixed-methods Feasibility Trial_v1.0_27Mar26.pdf
- Protocol file
- 50304 Consent Form_Stage Two (Interview)_v1.0_23Feb26.pdf
- Consent Form Stage Two (Interview)
- 50304 Consent Form_Stage One (Survey)_v1.0_23Feb26.pdf
- Consent Form Stage One (Survey)
- 50304 PIS_Stage Two (Interviews)_v1.1_01May26.pdf
- Stage Two (Interviews)
- 50304 PIS_Stage One_Evaluation of Intervention (Survey)_v1.1_01May26.pdf
- Stage One Evaluation of Intervention (Survey)
Editorial Notes
17/09/2026: Trial's existence confirmed by NHS HRA.
