Psychoeducation Group Intervention for FND

NCT03857347 | Unknown

• 2 other identifiers: CAHSS189/0518/NS/0137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Neurological Disorder

Keywords

FND; Functional Neurological Disorder; Psychoeducation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Brief Psychoeducation Intervention

EXPERIMENTAL

2 group session psychoeducation intervention feasibility study

Other: Psychoeducation Group for FND

Interventions

Psychoeducation Group for FND OTHER

he intervention is a psychoeducation based group.

Brief Psychoeducation Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Grampian: collaborator

Study Sites (1)

NHS Grampian

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Dr Pauline M Insch

  University of Edinburgh/NHS Grampian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 27, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)