Krishna Panchmatia
Manchester, M13 9NT, United Kingdom
NCT Number: NCT05941702
The goal of this clinical trial is to learn about an intervention package in individuals with Functional Neurological Disorder (FND). The main questions it aims to answer are:
* Is the intervention package acceptable to and feasible to deliver to individuals with FND? * Does the intervention package improve symptoms of FND?
Participants will be asked to engage in 8 weekly sessions of an intervention aimed to improve the perception of signals coming from the body (interoception). Participants will be asked to complete tasks between session practising tuning into signals from the body. Participants will also be asked to complete questionnaires measuring their psychological wellbeing, FND symptoms and interoception.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Manchester, M13 9NT, United Kingdom
The designed intervention is derived from the Integrative Cognitive Model (ICM) of medically unexplained symptoms and Psychogenic Non-Epileptic Seizures, (Brown, 2004; Ven den Bergh, Witthoft, Petersen, & Brown, 2017; Brown & Reuber, 2016). This model suggests that conscious body perceptions are interpretations of bottom-up signals influenced by top-down factors such as attention, beliefs, fears and emotional states. The model suggests that Functional Neurological Disorders are distortions in body awareness that arise when normal bodily signals are misinterpreted as noxious, due to a combination of top-down factors and the bodily signals themselves being weak. The proposed intervention targets several factors identified as important in this model, including imprecise bodily signals, poor emotion recognition and regulation, anxious beliefs and fears about symptoms and symptom-focussed processing. The intervention aims to sharpen signals from the body by reducing avoidance and misinterpretation of those signals and thereby improve body perception and interoceptive accuracy. If acceptable, feasible and effective, the proposed intervention would contribute to the literature for the Integrative Cognitive Model of FND and inform future interventions for individuals with FND.
Participants will be offered 8, 1-hour, online sessions, delivered weekly via Microsoft Teams. The psychological intervention will focus on developing skills to improve attunement to the signals from the body to the brain.
Follow-Up:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rationale for exclusion criteria is described in the study protocol
Information and protocol uploaded to documents.
Time frame: 8 weeks (span of intervention delivery)
This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
Time frame: 8 weeks (span of intervention delivery)
Measure of acceptability of intervention
Time frame: 8 weeks (span of the intervention delivery)
Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention
Time frame: Approximately 3 months - measure will be from baseline measure completion to end of therapy
Measure of treatment efficacy
Time frame: Approximately 3 months - measure will be from baseline completion until end of therapy
Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy
University of Manchester
Other
Feasibility and Acceptability of Body Signal Integration Training for Functional Neurological Disorder: A Case Series
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05723276
Conversion Disorder, Functional Neurological Disorder
London, United Kingdom
View Trial DetailsNCT06084325
Conversion Disorder, Functional Neurological Disorder
Bern, Canton of Bern, Switzerland
View Trial DetailsNCT05581810
Brain Concussion, Brain Diseases
North Vancouver, British Columbia, Canada
View Trial DetailsNCT06493344
Brain Damage, Chronic, Brain Diseases
Lamia, Phthiotis, Greece
View Trial Details