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Psychoeducation Group Intervention for FND

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ClinicalTrials.gov Identifier: NCT03857347
Recruitment Status : Not yet recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Edinburgh

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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.
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.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The Medical Outcome Study 36-item Short Form Health Survey (SF-36) [ 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 ]
    This outcome will measure potential change in self-reported health related quality of life using eight subscales



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857347


Contacts
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Contact: Dr Pauline M Insch 01224 559352 s1794701@sms.ed.ac.uk

Locations
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United Kingdom
NHS Grampian Active, not recruiting
Aberdeen, United Kingdom
Sponsors and Collaborators
University of Edinburgh
NHS Grampian
Investigators
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Principal Investigator: Dr Pauline M Insch University of Edinburgh/NHS Grampian

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03857347     History of Changes
Other Study ID Numbers: CAHSS189/05
18/NS/0137 ( Other Identifier: NHS Grampian Research Ethics Committee 2 )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
FND
Functional Neurological Disorder
Psychoeducation

Additional relevant MeSH terms:
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Nervous System Diseases
Conversion Disorder
Somatoform Disorders
Mental Disorders