Functional Neurological Symptom DisorderNCT07864454
Measuring Change in Individuals With Functional Neurological Symptom Disorder
An observational study of Functional Neurological Symptom Disorder, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Functional Neurological Symptom Disorders (FNSD) are one of the commonest reasons why patients are referred to neurologists. They are as disabling as neurological disorders causing similar symptoms related to more readily demonstrable pathophysiological or structural changes, however, FNSD are more commonly associated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Neurological Symptom Disorder
- What is being tested?
- STH Specialist Neurology Pyschotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with FNSD without a history of/current psychotherapy treatment; Patients with FNSD/NEAD who have just completed psychotherapy (post-pt); Patients with FNSD/NEAD who are about to begin psychotherapy (curr-pt); 5.4.4 Healthy control participants (HC)
Who may be able to join
- A clinically firm diagnosis of FNSD/NEAD
- No history or not currently receiving psychotherapy treatment
- Over the age of 18 years
- Able to complete the self-report questionnaires without assistance
- Able to give informed consent
Who cannot join
- People who are unable to give informed consent
- People who are unable to complete the self-report questionnaires unaided
- People whose diagnosis remains uncertain
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS FT
Sheffield, South Yorkshire, S10 2JF
About this study
Functional Neurological Symptom Disorders (FNSD) are one of the commonest reasons why patients are referred to neurologists. They are as disabling as neurological disorders causing similar symptoms related to more readily demonstrable pathophysiological or structural changes, however, FNSD are more commonly associated with psychiatric comorbidities. Psychotherapy is a treatment option for FNSD although there is still a dearth of reliable evidence that psychotherapy works for FNSD or how it may help. This is partly due to the nature of psychotherapeutic interventions but also to the difficulties associated with studying treatment outcome in a patient population that is highly heterogeneous in terms of aetiology and clinical presentation. This study contributes to a larger research project that is examining the efficacy of specialist psychotherapy for patients with FNSD utilising a range of approaches including objective cognitive and behavioural measures and subsequently exploring the reliability and usefulness of different outcome measurement approaches in this patient group. This study specifically aims to assess whether psychotherapy treatment in FNSD infers any change in cognitive behaviours of impulsivity and biases in the processing of emotional information. FNSD patients will complete two computer-based tasks and health-related questionnaires before, immediately after and at 6-months follow up after completing psychotherapy treatment sessions to measure any treatment-associated improvements. Data collected from patients not receiving any psychotherapy and participants without FNSD will provide longitudinal and cross-sectional control data respectively.
- Conditions
- Functional Neurological Symptom Disorder
- Being tested
- STH Specialist Neurology Pyschotherapy
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STH Specialist Neurology PyschotherapyBehavioural
The Neurology psychotherapy service at STH provides care as standard practice to the patient population of focus in this study. Patients enter the psychotherapy service by referral from their consultant and an initial assessment comprising an hour-long semi-structured interview in which the patient and therapist decide in collaboration whether therapy would be useful. Patients are assigned to a therapist based on therapist availability.
The service offers interventions with a flexible maximum of 20 sessions each 50 minutes long. Initially, a patient is booked for 4-6 sessions after which a collaborative progress review takes place. At this point, a further 4-6 sessions will be booked together, or a final session planned to end therapy and plan for discharge. In some circumstances, it is clear that a full 20 sessions would be beneficial, and patients are contracted. In other cases, therapy continues to be reviewed every 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm - No Pyschotherapy | Not described | |
| Current Pyschotherapy | Not described Receives: Behavioral: STH Specialist Neurology Pyschotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay discounting measure to assess the rate of discounting across delays and probabilities
The discounting measure used in the present study will mimic that of the EMOTICOM battery, adapted from previous studies done on discounting process (Malesza and Ostaszewski, 2013; Malesza, 2019) The discounting measure will assess the rate of discounting across delays and probabilities.
Measured: Baseline
Negative affective priming: evaluative categorisation task
Measured: Baseline
Secondary outcomes (6)
Generalized Anxiety Disorder Assessment (GAD-7)
The Generalized Anxiety Disorder Assessment (GAD-7) is a 7 item self-report questionnaire, designed to assess symptoms of anxiety experienced over the past 2 weeks.
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9 item self-report questionnaire measuring symptoms of depression over the past 2 weeks.
Measured: Baseline
EuroQol 5-Dimension- 3 level (EQ-5D-3L)
The 3-level version of EQ-5D (EQ-5D-3L) was introduced in 1990 by the EuroQol Group.
Measured: Baseline
Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) is a widely used and well-validated self-report measure designed to assess multiple aspects of emotion regulation.
Measured: Baseline
The self-Efficacy, Assertiveness, Social support, self-awareness and hElpful questionnaire (EASE)
The self-Efficacy, Assertiveness, Social support, self-awareness and hElpful questionnaire (EASE) is a novel patient-reported outcome measure designed to detect psychotherapy-related change.
Measured: Baseline
Mood Zoom Questionnaire
The Mood Zoom (MZ) questionnaire was conceived as part of the AMoSS study to provide a compact daily assessment of mood variability delivered via a smartphone application.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological Symptom DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864454
- Sponsor's protocol ID
- STH21490
- Other IDs
- IRAS:292166/STH21490
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2024
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Change in Individuals With Functional Neurological Symptom Disorder
- ClinicalTrials.gov ID
- NCT07864454
- Acronym / sponsor ID
- STH21490
- Conditions
- Functional Neurological Symptom Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 7 Oct 2026 (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.
Functional Neurological Symptom Disorders (FNSD) are one of the commonest reasons why patients are referred to neurologists. They are as disabling as neurological disorders causing similar symptoms related to more readily demonstrable pathophysiological or structural changes, however, FNSD are more commonly associated with psychiatric comorbidities. Psychotherapy is a treatment option for FNSD although there is still a dearth of reliable evidence that psychotherapy works for FNSD or how it may help. This is partly due to the nature of psychotherapeutic interventions but also to the difficulties associated with studying treatment outcome in a patient population that is highly heterogeneous in terms of aetiology and clinical presentation. This study contributes to a larger research project that is examining the efficacy of specialist psychotherapy for patients with FNSD utilising a range of approaches including objective cognitive and behavioural measures and subsequently exploring the reliability and usefulness of different outcome measurement approaches in this patient group. This study specifically aims to assess whether psychotherapy treatment in FNSD infers any change in cognitive behaviours of impulsivity and biases in the processing of emotional information. FNSD patients will complete two computer-based tasks and health-related questionnaires before, immediately after and at 6-months follow up after completing psychotherapy treatment sessions to measure any treatment-associated improvements. Data collected from patients not receiving any psychotherapy and participants without FNSD will provide longitudinal and cross-sectional control data respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm - No Pyschotherapy | – | – |
| Current Pyschotherapy | – | Behavioral: STH Specialist Neurology Pyschotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with FNSD without a history of/current psychotherapy treatment; Patients with FNSD/NEAD who have just completed psychotherapy (post-pt); Patients with FNSD/NEAD who are about to begin psychotherapy (curr-pt); 5.4.4 Healthy control participants (HC)
Key inclusion criteria (5 listed)
- A clinically firm diagnosis of FNSD/NEAD
- No history or not currently receiving psychotherapy treatment
- Over the age of 18 years
- Able to complete the self-report questionnaires without assistance
- Able to give informed consent
Key exclusion criteria (3 listed)
- People who are unable to give informed consent
- People who are unable to complete the self-report questionnaires unaided
- People whose diagnosis remains uncertain
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 |
|---|---|---|
| STH Specialist Neurology PyschotherapyThe Neurology psychotherapy service at STH provides care as standard practice to the patient population of focus in this study. Patients enter the psychotherapy service by referral from their consultant and an initial assessment comprising an hour-long semi-structured interview in which the patient and therapist decide in collaboration whether therapy would be useful. Patients are assigned to a therapist based on therapist availability. The service offers interventions with a flexible maximum of 20 sessions each 50 minutes long. Initially, a patient is booked for 4-6 sessions after which a collaborative progress review takes place. At this point, a further 4-6 sessions will be booked together, or a final session planned to end therapy and plan for discharge. In some circumstances, it is clear that a full 20 sessions would be beneficial, and patients are contracted. In other cases, therapy continues to be reviewed every 4-6 weeks. | Behavioural | Current Pyschotherapy |
Primary outcome
Delay discounting measure to assess the rate of discounting across delays and probabilities
Time frame: Baseline
The discounting measure used in the present study will mimic that of the EMOTICOM battery, adapted from previous studies done on discounting process (Malesza and Ostaszewski, 2013; Malesza, 2019) The discounting measure will assess the rate of discounting across delays and probabilities.
Negative affective priming: evaluative categorisation task
Time frame: Baseline
6 secondary outcomes
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
EuroQol 5-Dimension- 3 level (EQ-5D-3L)
Time frame: Baseline
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline
The self-Efficacy, Assertiveness, Social support, self-awareness and hElpful questionnaire (EASE)
Time frame: Baseline
Mood Zoom Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Symptom Disorder, run by Sheffield Teaching Hospitals NHS Foundation 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 3 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: finished, as of the sponsor's last update on 30 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay discounting measure to assess the rate of discounting across delays and probabilities (time frame: Baseline). The study lists 2 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 30 Oct 2026.