Functional Neurological DisorderNCT05941702
Body Signal Integration Training: A Case Series
A study testing Body Signal Integration Training in people with Functional Neurological Disorder, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to learn about an intervention package in individuals with Functional Neurological Disorder (FND). The main questions it aims to answer are: Is the intervention package acceptable to and feasible to deliver to individuals with FND? Does the intervention package improve symptoms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- Body Signal Integration Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2023to 26 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently experiencing FND symptoms, as measured on items 34-47 on the SOMS-7 (excluding seizures and hallucinations). The study is aiming to investigate the feasibility of an intervention for individuals with FND.
- Confirmation of diagnosis of FND (through letter from medical doctor) to ensure participants have a diagnosis of FND and are therefore the target audience for the intervention
- Willing and able to participate in remote therapy. The intervention will be delivered remotely so participants must be willing to engage with remote therapy.
- Able to converse in English proficiently without support from a link worker. The study will not be using interpreters and so an ability to converse proficiently in English to be able to engage with the intervention is needed.
- Residing in the UK for the duration of the study, this is in order to develop crisis and risk management plans for participants should they experience any negative effects from therapy or any risks be expressed throughout the course of the intervention.
Who cannot join
- Currently undergoing any other psychological therapy
- Previous experience of a mindfulness-based intervention targeting FND.
- Individuals with symptoms of epilepsy and loss of consciousness.
- Symptoms of psychosis (as assessed on the Comprehensive Assessment of At-Risk Mental State, CAARMS).
- Diagnosis of any type of Personality Disorder
- Active plans of self-harm and/or suicide. Potential participants will be asked to complete the risk items on the CORE-OM and will be interviewed around these. This is to ensure the safety of participants engaging in novel therapy and to manage the risks of any potential adverse side-effects of therapy
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- History of prior suicide attempts, to manage the risks of causing negative side effects of therapy
- Any difficulties with alcohol or substance misuse.
- Individuals with active symptoms of Post Traumatic Stress Disorder (PTSD) i.e., having current symptoms of nightmares and flashbacks.
- Individuals with symptoms of an eating disorder.
- Rationale for exclusion criteria is described in the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Body Signal Integration Training for Functional Neurological Disorder: A Case Series
The goal of this clinical trial is to learn about an intervention package in individuals with Functional Neurological Disorder (FND). The main questions it aims to answer are:
- Is the intervention package acceptable to and feasible to deliver to individuals with FND?
- Does the intervention package improve symptoms of FND?
Participants will be asked to engage in 8 weekly sessions of an intervention aimed to improve the perception of signals coming from the body (interoception). Participants will be asked to complete tasks between session practising tuning into signals from the body. Participants will also be asked to complete questionnaires measuring their psychological wellbeing, FND symptoms and interoception.
Read the detailed description
The designed intervention is derived from the Integrative Cognitive Model (ICM) of medically unexplained symptoms and Psychogenic Non-Epileptic Seizures, (Brown, 2004; Ven den Bergh, Witthoft, Petersen, \& Brown, 2017; Brown \& Reuber, 2016). This model suggests that conscious body perceptions are interpretations of bottom-up signals influenced by top-down factors such as attention, beliefs, fears and emotional states. The model suggests that Functional Neurological Disorders are distortions in body awareness that arise when normal bodily signals are misinterpreted as noxious, due to a combination of top-down factors and the bodily signals themselves being weak. The proposed intervention targets several factors identified as important in this model, including imprecise bodily signals, poor emotion recognition and regulation, anxious beliefs and fears about symptoms and symptom-focussed processing. The intervention aims to sharpen signals from the body by reducing avoidance and misinterpretation of those signals and thereby improve body perception and interoceptive accuracy. If acceptable, feasible and effective, the proposed intervention would contribute to the literature for the Integrative Cognitive Model of FND and inform future interventions for individuals with FND.
Participants will be offered 8, 1-hour, online sessions, delivered weekly via Microsoft Teams. The psychological intervention will focus on developing skills to improve attunement to the signals from the body to the brain.
- The sessions will involve engaging in various exercises tuning into the body under different circumstances. Participants will be asked to tune into how particular objects feel in their hands. Participants may be presented with images or scenarios to make them feel a little happy or sad and then will be asked to tune into how the body feels in response to them.
- Participants will be asked to complete weekly measures online via Qualtrics survey, they will be asked to do this in the 10-15 minutes prior to their session commencing.
- A full manual of the intervention plan will be uploaded to documents.
- Following the final session of treatment, a date to complete a one-month follow up will be arranged with the participant.
Follow-Up:
- One month following the end of psychological therapy, a session will be attended remotely via Microsoft Teams by participants.
- During this session, all pre-treatment, weekly and post-treatment measures will be re-administered including questionnaires measuring satisfaction with therapy.
- Conditions
- Functional Neurological Disorder
- Being tested
- Body Signal Integration Training
- Keywords
- Intervention, Interoception, Body Awareness
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Signal Integration TrainingBehavioural
Information and protocol uploaded to documents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Receives: Behavioral: Body Signal Integration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Complete 80% of the Intervention
This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
Measured: 8 weeks (span of intervention delivery)
Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction
Measure of acceptability of intervention
Measured: 8 weeks (span of intervention delivery)
Number of Serious Adverse Reactions as Evidenced by Significant Increase in Distress or Symptom Rating on Euroqol Health Questionnaire (EQ5D), Clinical Outcomes in Routine Evaluation (CORE-10) or FND Questionnaire
Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention
Measured: 8 weeks (span of the intervention delivery)
Secondary outcomes (2)
Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7)
Measure of treatment efficacy
Measured: Approximately 3 months - measure will be from baseline measure completion to end of therapy
Number of Particip
Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy
Measured: Approximately 3 months - measure will be from baseline completion until end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start19 Sep 2023
- Primary completion26 Jan 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Neurological 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishna Panchmatia, University of Manchester
- Investigators
- Krishna Panchmatia, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941702
- Sponsor's protocol ID
- KPanchmatia
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Body Signal Integration Training for Functional Neurological Disorder: A Case Series
- ClinicalTrials.gov ID
- NCT05941702
- Acronym / sponsor ID
- KPanchmatia
- Conditions
- Functional Neurological Disorder
- Keywords
- Intervention, Interoception, Body Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about an intervention package in individuals with Functional Neurological Disorder (FND). The main questions it aims to answer are:
- Is the intervention package acceptable to and feasible to deliver to individuals with FND?
- Does the intervention package improve symptoms of FND?
Participants will be asked to engage in 8 weekly sessions of an intervention aimed to improve the perception of signals coming from the body (interoception). Participants will be asked to complete tasks between session practising tuning into signals from the body. Participants will also be asked to complete questionnaires measuring their psychological wellbeing, FND symptoms and interoception.
Detailed description
The designed intervention is derived from the Integrative Cognitive Model (ICM) of medically unexplained symptoms and Psychogenic Non-Epileptic Seizures, (Brown, 2004; Ven den Bergh, Witthoft, Petersen, \& Brown, 2017; Brown \& Reuber, 2016). This model suggests that conscious body perceptions are interpretations of bottom-up signals influenced by top-down factors such as attention, beliefs, fears and emotional states. The model suggests that Functional Neurological Disorders are distortions in body awareness that arise when normal bodily signals are misinterpreted as noxious, due to a combination of top-down factors and the bodily signals themselves being weak. The proposed intervention targets several factors identified as important in this model, including imprecise bodily signals, poor emotion recognition and regulation, anxious beliefs and fears about symptoms and symptom-focussed processing. The intervention aims to sharpen signals from the body by reducing avoidance and misinterpretation of those signals and thereby improve body perception and interoceptive accuracy. If acceptable, feasible and effective, the proposed intervention would contribute to the literature for the Integrative Cognitive Model of FND and inform future interventions for individuals with FND.
Participants will be offered 8, 1-hour, online sessions, delivered weekly via Microsoft Teams. The psychological intervention will focus on developing skills to improve attunement to the signals from the body to the brain.
- The sessions will involve engaging in various exercises tuning into the body under different circumstances. Participants will be asked to tune into how particular objects feel in their hands. Participants may be presented with images or scenarios to make them feel a little happy or sad and then will be asked to tune into how the body feels in response to them.
- Participants will be asked to complete weekly measures online via Qualtrics survey, they will be asked to do this in the 10-15 minutes prior to their session commencing.
- A full manual of the intervention plan will be uploaded to documents.
- Following the final session of treatment, a date to complete a one-month follow up will be arranged with the participant.
Follow-Up:
- One month following the end of psychological therapy, a session will be attended remotely via Microsoft Teams by participants.
- During this session, all pre-treatment, weekly and post-treatment measures will be re-administered including questionnaires measuring satisfaction with therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Body Signal Integration TrainingFull session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently experiencing FND symptoms, as measured on items 34-47 on the SOMS-7 (excluding seizures and hallucinations). The study is aiming to investigate the feasibility of an intervention for individuals with FND.
- Confirmation of diagnosis of FND (through letter from medical doctor) to ensure participants have a diagnosis of FND and are therefore the target audience for the intervention
- Willing and able to participate in remote therapy. The intervention will be delivered remotely so participants must be willing to engage with remote therapy.
- Able to converse in English proficiently without support from a link worker. The study will not be using interpreters and so an ability to converse proficiently in English to be able to engage with the intervention is needed.
- Residing in the UK for the duration of the study, this is in order to develop crisis and risk management plans for participants should they experience any negative effects from therapy or any risks be expressed throughout the course of the intervention.
Key exclusion criteria (11 listed)
- Currently undergoing any other psychological therapy
- Previous experience of a mindfulness-based intervention targeting FND.
- Individuals with symptoms of epilepsy and loss of consciousness.
- Symptoms of psychosis (as assessed on the Comprehensive Assessment of At-Risk Mental State, CAARMS).
- Diagnosis of any type of Personality Disorder
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 |
|---|---|---|
| Body Signal Integration TrainingInformation and protocol uploaded to documents. | Behavioural | Intervention |
Primary outcome
Number of Participants That Complete 80% of the Intervention
Time frame: 8 weeks (span of intervention delivery)
This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction
Time frame: 8 weeks (span of intervention delivery)
Measure of acceptability of intervention
Number of Serious Adverse Reactions as Evidenced by Significant Increase in Distress or Symptom Rating on Euroqol Health Questionnaire (EQ5D), Clinical Outcomes in Routine Evaluation (CORE-10) or FND Questionnaire
Time frame: 8 weeks (span of the intervention delivery)
Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention
2 secondary outcomes
Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7)
Time frame: Approximately 3 months - measure will be from baseline measure completion to end of therapy
Number of Particip
Time frame: Approximately 3 months - measure will be from baseline completion until end of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Krishna Panchmatia principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Signal Integration Training in people with Functional Neurological Disorder, run by University of Manchester 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 11 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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Complete 80% of the Intervention (time frame: 8 weeks (span of intervention delivery)). The study lists 3 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 19 Sep 2024.