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Psychoeducation Group Intervention for FND

Primary Purpose

Functional Neurological Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychoeducation Group for FND
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Functional Neurological Disorder focused on measuring FND, Functional Neurological Disorder, Psychoeducation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Grampian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brief Psychoeducation Intervention

Arm Description

2 group session psychoeducation intervention feasibility study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2019
Last Updated
October 7, 2019
Sponsor
University of Edinburgh
Collaborators
NHS Grampian
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1. Study Identification

Unique Protocol Identification Number
NCT03857347
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Grampian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Disorder
Keywords
FND, Functional Neurological Disorder, Psychoeducation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Psychoeducation Intervention
Arm Type
Experimental
Arm Description
2 group session psychoeducation intervention feasibility study
Intervention Type
Other
Intervention Name(s)
Psychoeducation Group for FND
Intervention Description
he intervention is a psychoeducation based group.
Primary Outcome Measure Information:
Title
The Medical Outcome Study 36-item Short Form Health Survey (SF-36)
Description
This outcome will measure potential change in self-reported health related quality of life using eight subscales
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Pauline M Insch
Organizational Affiliation
University of Edinburgh/NHS Grampian
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Grampian
City
Aberdeen
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychoeducation Group Intervention for FND

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