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Clinical Trials/NCT03857347
NCT03857347
Unknown
N/A

A Feasibility Study for a Psycho-education Intervention for People With a Functional Neurological Disorder.

University of Edinburgh1 site in 1 country30 target enrollmentMay 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Functional Neurological Disorder
Sponsor
University of Edinburgh
Enrollment
30
Locations
1
Primary Endpoint
The Medical Outcome Study 36-item Short Form Health Survey (SF-36)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
September 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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
  • Those unable to travel independently to attend group sessions due to the severity of their symptoms

Outcomes

Primary Outcomes

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

Study Sites (1)

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