Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05941702 |
Other study ID # |
KPanchmatia |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 19, 2023 |
Est. completion date |
February 2024 |
Study information
Verified date |
November 2023 |
Source |
University of Manchester |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.