Psychoeducation Group Intervention for FND

Sponsor

University of Edinburgh (Other)

Overall Status

Unknown status

CT.gov ID

NCT03857347

Collaborator

NHS Grampian (Other)

Enrollment

Location

Arm

16.1

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Functional Neurological Disorder	Other: Psychoeducation Group for FND	N/A

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Psychoeducation Intervention 2 group session psychoeducation intervention feasibility study	Other: Psychoeducation Group for FND he intervention is a psychoeducation based group.

Arm

Intervention/Treatment

Experimental: Brief Psychoeducation Intervention

2 group session psychoeducation intervention feasibility study

Other: Psychoeducation Group for FND

he intervention is a psychoeducation based group.

Outcome Measures

Primary Outcome Measures

The Medical Outcome Study 36-item Short Form Health Survey (SF-36) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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