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Body Signal Integration Training: A Case Series

Primary Purpose

Functional Neurological Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Body Signal Integration Training
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Neurological Disorder focused on measuring Intervention, Interoception, Body Awareness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krishna PanchmatiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants that complete 80% of the intervention
This is a measure of adherence, feasibility and acceptability of the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
Number of participants rating the therapy as acceptable on questionnaire of therapy satisfaction
Measure of acceptability of intervention
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

Secondary Outcome Measures

Number of participants showing a 30% reliable change reduction in Core FND symptoms as measured by Screening for Somatic Symptom Disorders (SOMS-7) and FND questionnaire
Measure of treatment efficacy
Rate of Change and Clinically Significant Change of Interoception as measured by Multidimensional Assessment of Interoceptive Awareness
Measure of treatment efficacy in improving interoception

Full Information

First Posted
July 3, 2023
Last Updated
September 19, 2023
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT05941702
Brief Title
Body Signal Integration Training: A Case Series
Official Title
Feasibility and Acceptability of Body Signal Integration Training for Functional Neurological Disorder: A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Disorder
Keywords
Intervention, Interoception, Body Awareness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case Series
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body Signal Integration Training
Intervention Description
Information and protocol uploaded to documents.
Primary Outcome Measure Information:
Title
Number of participants that complete 80% of the intervention
Description
This is a measure of adherence, feasibility and acceptability of the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
Time Frame
8 weeks (span of intervention delivery)
Title
Number of participants rating the therapy as acceptable on questionnaire of therapy satisfaction
Description
Measure of acceptability of intervention
Time Frame
8 weeks (span of intervention delivery)
Title
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
Description
Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention
Time Frame
8 weeks (span of the intervention delivery)
Secondary Outcome Measure Information:
Title
Number of participants showing a 30% reliable change reduction in Core FND symptoms as measured by Screening for Somatic Symptom Disorders (SOMS-7) and FND questionnaire
Description
Measure of treatment efficacy
Time Frame
Approximately 3 months - measure will be from baseline measure completion to end of therapy
Title
Rate of Change and Clinically Significant Change of Interoception as measured by Multidimensional Assessment of Interoceptive Awareness
Description
Measure of treatment efficacy in improving interoception
Time Frame
Approximately 3 months - measure will be from baseline completion until end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krishna Panchmatia
Phone
+447500226391
Email
krishna.panchmatia@postgrad.manchester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna Panchmatia
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishna Panchmatia
City
Manchester
ZIP/Postal Code
M13 9NT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Panchmatia
Email
krishna.panchmatia@postgrad.manchester.ac.uk
First Name & Middle Initial & Last Name & Degree
Richard Brown

12. IPD Sharing Statement

Plan to Share IPD
No

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Body Signal Integration Training: A Case Series

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