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Clinical Trial Summary

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.


Clinical Trial Description

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. - The sessions will involve engaging in various exercises tuning into the body under different circumstances. Participants will be asked to tune into how particular objects feel in their hands. Participants may be presented with images or scenarios to make them feel a little happy or sad and then will be asked to tune into how the body feels in response to them. - Participants will be asked to complete weekly measures online via Qualtrics survey, they will be asked to do this in the 10-15 minutes prior to their session commencing. - A full manual of the intervention plan will be uploaded to documents. - Following the final session of treatment, a date to complete a one-month follow up will be arranged with the participant. Follow-Up: - One month following the end of psychological therapy, a session will be attended remotely via Microsoft Teams by participants. - During this session, all pre-treatment, weekly and post-treatment measures will be re-administered including questionnaires measuring satisfaction with therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05941702
Study type Interventional
Source University of Manchester
Contact
Status Active, not recruiting
Phase N/A
Start date September 19, 2023
Completion date February 2024

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