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
|Condition or disease||Intervention/treatment||Phase|
|Functional Neurological Disorder||Other: Psychoeducation Group for FND||Not Applicable|
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 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|
Experimental: Brief Psychoeducation Intervention
2 group session psychoeducation intervention feasibility study
Other: Psychoeducation Group for FND
he intervention is a psychoeducation based group.
- 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
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
|Contact: Dr Pauline M Insch||01224 firstname.lastname@example.org|
|NHS Grampian||Active, not recruiting|
|Aberdeen, United Kingdom|
|Principal Investigator:||Dr Pauline M Insch||University of Edinburgh/NHS Grampian|