N/A
N=8
Body Signal Integration Training: A Case Series
Functional Neurological Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05941702 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants That Complete 80% of the Intervention — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Body Signal Integration Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Manchester
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Complete 80% of the Intervention |
7 | — |
| PRIMARY Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction |
7 | — |
| PRIMARY Number of Serious Adverse Reactions as Evidenced by Significant Increase in Distress or Symptom Rating on Euroqol Health Questionnaire (EQ5D), Clinical Outcomes in Routine Evaluation (CORE-10) or FND Questionnaire |
— | — |
| SECONDARY Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7) |
3 | — |
| SECONDARY Number of Particip |
5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Currently experiencing FND symptoms, as measured on items 34-47 on the SOMS-7 (excluding seizures and hallucinations). The study is aiming to investigate the feasibility of an intervention for individuals with FND.
- Confirmation of diagnosis of FND (through letter from medical doctor) to ensure participants have a diagnosis of FND and are therefore the target audience for the intervention
- Willing and able to participate in remote therapy. The intervention will be delivered remotely so participants must be willing to engage with remote therapy.
- Able to converse in English proficiently without support from a link worker. The study will not be using interpreters and so an ability to converse proficiently in English to be able to engage with the intervention is needed.
- Residing in the UK for the duration of the study, this is in order to develop crisis and risk management plans for participants should they experience any negative effects from therapy or any risks be expressed throughout the course of the intervention.
Exclusion Criteria
- Currently undergoing any other psychological therapy
- Previous experience of a mindfulness-based intervention targeting FND.
- Individuals with symptoms of epilepsy and loss of consciousness.
- Symptoms of psychosis (as assessed on the Comprehensive Assessment of At-Risk Mental State, CAARMS).
- Diagnosis of any type of Personality Disorder
- Active plans of self-harm and/or suicide. Potential participants will be asked to complete the risk items on the CORE-OM and will be interviewed around these. This is to ensure the safety of participants engaging in novel therapy and to manage the risks of any potential adverse side-effects of therapy
- History of prior suicide attempts, to manage the risks of causing negative side effects of therapy
- Any difficulties with alcohol or substance misuse.
- Individuals with active symptoms of Post Traumatic Stress Disorder (PTSD) i.e., having current symptoms of nightmares and flashbacks.
- Individuals with symptoms of an eating disorder.
Rationale for exclusion criteria is described in the study protocol
Data sourced from ClinicalTrials.gov (NCT05941702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.