Functional Neurological DisorderNCT03857347
Psychoeducation Group Intervention for FND
A study testing Psychoeducation Group for FND in people with Functional Neurological Disorder, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- Psychoeducation Group for FND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to Sep 2020
- Phase
- Interventional
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 18-64 years with a diagnosis of FND
Who cannot join
- Anyone the clinical neuropsychologist/neurologist feels, as a result of their clinical judgement, lacks capacity to consent.
- People who are unable to understand the information sheet due to English not being their first language.
- Severe sensory impairment.
- Anyone experiencing active severe psychiatric symptoms
- A dependency on alcohol or recreational drugs
- Learning disability as classified by ICD 10.
- Those unable to travel independently to attend group sessions due to the severity of their symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study for a Psycho-education Intervention for People With a Functional Neurological Disorder.
This study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients
Read the detailed description
A Functional Neurological Disorder (FND) is when the brain has difficulties sending and receiving signals . As a result people can experience problems in how their body and senses work, but there is no physical problem to treat.
Currently there is little treatment to offer after diagnosis, this study will investigate the feasibility and potential benefit to offering a group intervention to people with FND. This group intervention will offer chance to access information and the opportunity to meet others with the similar difficulties. Eligible participants will be those currently attending neurology clinics within NHS Grampian. Participants will complete prior to, during and at 3 months after the group is completed. These measures include health care use of participants, reported physical symptoms, subjective quality of ife and mood we will also take a brief measure of attention and concentration. Reported physical symptoms, subjective quality of life and mood will also be collected before the first group and at the last group.
- Conditions
- Functional Neurological Disorder
- Being tested
- Psychoeducation Group for FND
- Keywords
- FND, Functional Neurological Disorder, Psychoeducation
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation Group for FNDOther
he intervention is a psychoeducation based group.
| Study group | Role | What they receive |
|---|---|---|
| Brief Psychoeducation Intervention | Experimental | 2 group session psychoeducation intervention feasibility study Receives: Other: Psychoeducation Group for FND |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Medical Outcome Study 36-item Short Form Health Survey (SF-36)
This outcome will measure potential change in self-reported health related quality of life using eight subscales
Measured: Baseline, Change from Baseline at Time 1 (2 weeks prior to group), Change from Baseline at Time 2 (4 weeks after Time 1), Time 3 change from baseline 3 months from Time 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 May 2019
- Primary completionDec 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Data will be explored using the reliable and clinically significant change analysis (Morely, Williams \& Hussain, 2008). This analysis allows pre and post treatment scores to be compared to see if participants have achieved a level of difference that could be categorized as real and not due to measurement error. Furthermore this score can be helpful to determine if the change seen is clinically significant.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Dr Pauline M Insch, Principal investigator, University of Edinburgh/NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857347
- Sponsor's protocol ID
- CAHSS189/05
- Other IDs
- 18/NS/0137
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2019
- Last updated
- 9 Oct 2019
- 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 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Psycho-education Intervention for People With a Functional Neurological Disorder.
- ClinicalTrials.gov ID
- NCT03857347
- Acronym / sponsor ID
- CAHSS189/05
- Conditions
- Functional Neurological Disorder
- Keywords
- FND, Functional Neurological Disorder, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Feb 2019 (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.
This study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients
Detailed description
A Functional Neurological Disorder (FND) is when the brain has difficulties sending and receiving signals . As a result people can experience problems in how their body and senses work, but there is no physical problem to treat.
Currently there is little treatment to offer after diagnosis, this study will investigate the feasibility and potential benefit to offering a group intervention to people with FND. This group intervention will offer chance to access information and the opportunity to meet others with the similar difficulties. Eligible participants will be those currently attending neurology clinics within NHS Grampian. Participants will complete prior to, during and at 3 months after the group is completed. These measures include health care use of participants, reported physical symptoms, subjective quality of ife and mood we will also take a brief measure of attention and concentration. Reported physical symptoms, subjective quality of life and mood will also be collected before the first group and at the last group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data will be explored using the reliable and clinically significant change analysis (Morely, Williams \& Hussain, 2008). This analysis allows pre and post treatment scores to be compared to see if participants have achieved a level of difference that could be categorized as real and not due to measurement error. Furthermore this score can be helpful to determine if the change seen is clinically significant.
| Arm | Type | Receives |
|---|---|---|
| Brief Psychoeducation Intervention | Experimental | Other: Psychoeducation Group for FND2 group session psychoeducation intervention feasibility study |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals aged between 18-64 years with a diagnosis of FND
Key exclusion criteria (7 listed)
- Anyone the clinical neuropsychologist/neurologist feels, as a result of their clinical judgement, lacks capacity to consent.
- People who are unable to understand the information sheet due to English not being their first language.
- Severe sensory impairment.
- Anyone experiencing active severe psychiatric symptoms
- A dependency on alcohol or recreational drugs
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 |
|---|---|---|
| Psychoeducation Group for FNDhe intervention is a psychoeducation based group. | Other | Brief Psychoeducation Intervention |
Primary outcome
The Medical Outcome Study 36-item Short Form Health Survey (SF-36)
Time frame: Baseline, Change from Baseline at Time 1 (2 weeks prior to group), Change from Baseline at Time 2 (4 weeks after Time 1), Time 3 change from baseline 3 months from Time 2
This outcome will measure potential change in self-reported health related quality of life using eight subscales
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- 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.
Dr Pauline M Insch principal investigator
University of Edinburgh/NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation Group for FND in people with Functional Neurological Disorder, run by University of Edinburgh 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Oct 2019. 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?
Results are not available in the source record.
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?
The Medical Outcome Study 36-item Short Form Health Survey (SF-36) (time frame: Baseline, Change from Baseline at Time 1 (2 weeks prior to group), Change from Baseline at Time 2 (4 weeks after Time 1), Time 3 change from baseline 3 months from Time 2). 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 9 Oct 2019.