Psychoeducation Group Intervention for FND

Functional Neurological Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03857347
• Other study ID #: CAHSS189/05
• Secondary ID: 18/NS/0137
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases

Intervention

Other:
• Psychoeducation Group for FND
he intervention is a psychoeducation based group.

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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