Psychoeducation Group Intervention for FND | NCT03857347

Studies
Psychoeducation Group Intervention for FND

NCT03857347

Sponsor

University of Edinburgh

Status

Unknown status

Last Update Posted

Oct 9, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Functional Neurological Disorder

Interventions

Psychoeducation Group for FND

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
18/NS/0137	Other Identifier	NHS Grampian Research Ethics Committee 2

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jan 21, 2019

First Submission Date that Met QC Criteria

Feb 26, 2019

First Posted Date

Feb 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2019

Last Update Posted Date

Oct 9, 2019Actual

Name	Class
NHS Grampian	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brief Psychoeducation Intervention	Experimental	2 group session psychoeducation intervention feasibility study	Other: Psychoeducation Group for FND

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychoeducation Group for FND	Other	he intervention is a psychoeducation based group.	Brief Psychoeducation Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Pauline M Insch	University of Edinburgh/NHS Grampian	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Grampian		Aberdeen			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Sep 23, 2025
Reset	Oct 10, 2025
Release	Jan 13, 2026
Reset	Jan 29, 2026
Release	Feb 4, 2026
Reset	Feb 23, 2026
Release	May 6, 2026
Reset	Jun 1, 2026
Release	Jun 3, 2026
Reset	Jun 26, 2026

Submission Tracking

Estimated Results First Submitted Date

Sep 23, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 23, 2025			Oct 10, 2025
Jan 13, 2026

Condition Browse Module

MeSH Terms

ID	Term
D003291	Conversion Disorder

Ancestor Terms

ID	Term
D013001	Somatoform Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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.