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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:
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.
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.
Follow-Up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Signal Integration Training | Behavioral | Information and protocol uploaded to documents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7) | Measure of treatment efficacy | Approximately 3 months - measure will be from baseline measure completion to end of therapy |
| Number of Particip |
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Inclusion Criteria:
Exclusion Criteria:
Rationale for exclusion criteria is described in the study protocol
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| Name | Affiliation | Role |
|---|---|---|
| Krishna Panchmatia | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krishna Panchmatia | Manchester | M13 9NT | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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. Body Signal Integration Training: Information and protocol uploaded to documents. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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. Body Signal Integration Training: Information and protocol uploaded to documents. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Number of participants that completed intervention | Posted | Count of Participants | Participants | 8 weeks (span of intervention delivery) |
|
3 months
No unanticipated adverse events occurred or serious adverse events occurred. One individual reported increased awareness of FND symptoms and associated distress, they chose to drop out of the study and subsequently contacted researchers to inform symptoms had resolved - this was deemed an 'anticipated adverse reaction' to treatment. No further events/reactions occurred during the trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. Body Signal Integration Training: Information and protocol uploaded to documents. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological Distress | Social circumstances | Non-systematic Assessment | Stress caused by tuning into the body leading to greater perception of symptoms/distress associated with symptoms. In this instance, |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krishna Panchmatia | University of Manchester | 07857543272 | krishna.panchmatia@postgrad.manchester.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Jun 19, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2023 | Jul 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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Case Series
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Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy |
| Approximately 3 months - measure will be from baseline completion until end of therapy |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction | Measure of acceptability of intervention | Posted | Count of Participants | Participants | 8 weeks (span of intervention delivery) |
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| 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 | Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention | Number of participants that experienced adverse reaction to treatment | Posted | Count of Participants | Participants | 8 weeks (span of the intervention delivery) |
|
|
|
| Secondary | Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7) | Measure of treatment efficacy | Posted | Count of Participants | Participants | Approximately 3 months - measure will be from baseline measure completion to end of therapy |
|
|
|
| Secondary | Number of Particip | Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy | Posted | Count of Participants | Participants | Approximately 3 months - measure will be from baseline completion until end of therapy |
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| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
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