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CompletedNCT07864454Updated Oct 7, 2026

Measuring Change in Individuals With Functional Neurological Symptom Disorder

An observational study in Functional Neurological Symptom Disorder, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational

Updated Oct 7, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Functional Neurological Symptom Disorder

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03

In context

Conversion Disorder

102 studies on the registry are indexed under Conversion Disorder; 36 are open to participants now.

This study's enrollment of 122 is above the median of 60 across 42 observational studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 213 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • People who are unable to give informed consent
  • People who are unable to complete the self-report questionnaires unaided
  • People whose diagnosis remains uncertain
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • Control Arm - No Pyschotherapy
  • Current Pyschotherapy

    Behavioral: STH Specialist Neurology Pyschotherapy

Interventions

  • BehavioralSTH Specialist Neurology Pyschotherapy

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. Negative affective priming: evaluative categorisation task

    Time frame: Baseline

Secondary outcomes

  1. GAD-7

    The GAD-7 is a 7 item self-report questionnaire, designed to assess symptoms of anxiety experienced over the past 2 weeks.

    Time frame: Baseline

  2. Patient Health Questionnaire-9 (PHQ-9)

    The PHQ-9 is a 9 item self-report questionnaire measuring symptoms of depression over the past 2 weeks.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. Difficulties in Emotion Regulation Scale (DERS)

    The DERS is a widely used and well-validated self-report measure designed to assess multiple aspects of emotion regulation.

    Time frame: Baseline

  5. The self-Efficacy, Assertiveness, Social support, self-awareness and hElpful questionnaire (EASE)

    The EASE is a novel patient-reported outcome measure designed to detect psychotherapy-related change.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Sheffield Teaching Hospitals NHS FT
    Sheffield, South Yorkshire S10 2JF, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Feb 2023, 13 months.

Of 19 observational studies under Conversion Disorder, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2024
First posted
Oct 7, 2026
StartActual
Jan 1, 2022
Primary completionActual
Feb 1, 2023
CompletionActual
Feb 1, 2023
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864454
Collaborators
University of Sheffield
Responsible party
Sponsor
First posted
Oct 7, 2026
Start date
Jan 1, 2022
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023
Last update
Oct 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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