Clinical trial NCT03857347: Psychoeducation Group Intervention for FND
Official title: A Feasibility Study for a Psycho-education Intervention for People With a Functional Neurological Disorder.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Neurological Disorder
Keywords: FND
Functional Neurological Disorder
Psychoeducation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2019-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Individuals aged between 18-64 years with a diagnosis of FND

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Medical Outcome Study 36-item Short Form Health Survey (SF-36)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
Study officials:
affiliation: University of Edinburgh/NHS Grampian
name: Dr Pauline M Insch
role: PRINCIPAL_INVESTIGATOR
References: