Body Signal Integration Training: A Case Series

NCT05941702 | Completed Results

• 1 other identifier: KPanchmatia
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Neurological Disorder

Keywords

Intervention; Interoception; Body Awareness

Outcome Measures

Primary Outcomes (3)

• Number of Participants That Complete 80% of the Intervention

  This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence

  8 weeks (span of intervention delivery)

• Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction

  Measure of acceptability of intervention

  8 weeks (span of intervention delivery)

• 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

  Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention

  8 weeks (span of the intervention delivery)

Secondary Outcomes (2)

• Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7)

  Approximately 3 months - measure will be from baseline measure completion to end of therapy

• Number of Particip

  Approximately 3 months - measure will be from baseline completion until end of therapy

Study Arms (1)

Intervention

EXPERIMENTAL

Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state.

Behavioral: Body Signal Integration Training

Interventions

Body Signal Integration Training BEHAVIORAL

Information and protocol uploaded to documents.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Krishna Panchmatia

Manchester, M13 9NT, United Kingdom

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Results Point of Contact

• Title: Krishna Panchmatia
• Organization: University of Manchester

krishna.panchmatia@postgrad.manchester.ac.uk

07857543272

Study Officials

• Krishna Panchmatia

  University of Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: Case Series

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: September 19, 2023
• Primary Completion: January 26, 2024
• Study Completion: February 26, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)