An interventional study of Body Signal Integration Training in Functional Neurological Disorder, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Manchester · Not applicable, Interventional, and Treatment
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:
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 8 is below the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rationale for exclusion criteria is described in the study protocol
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
Information and protocol uploaded to documents.
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
Time frame: 8 weeks (span of intervention delivery)
Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction
Measure of acceptability of intervention
Time frame: 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
Time frame: 8 weeks (span of the intervention delivery)
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
Time frame: Approximately 3 months - measure will be from baseline measure completion to end of therapy
Number of Particip
Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy
Time frame: Approximately 3 months - measure will be from baseline completion until end of therapy
| Milestone | Intervention |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
This is a measure of adherence to the intervention. 80% of participants attending 80% of sessions offered will be considered acceptable adherence
| Participants | Intervention |
|---|---|
| Number of Participants That Complete 80% of the Intervention | 7 |
Measure of acceptability of intervention
| Participants | Intervention |
|---|---|
| Number of Participants Rating the Therapy as Acceptable on Questionnaire of Therapy Satisfaction | 7 |
Number of serious adverse reactions will be a measure of feasibility and acceptability of the intervention
| Participants | 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 | 0 |
Measure of treatment efficacy
| Participants | Intervention |
|---|---|
| Number of Participants Showing a Reliable Change Reduction in Core FND Symptoms as Measured by Screening for Somatic Symptom Disorders (SOMS-7) | 3 |
Number of Participants with a Clinically Significant Change of Interoception Measuring Treatment Efficacy
| Participants | Intervention |
|---|---|
| Number of Particip | 5 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | Intervention |
|---|---|
| Psychological DistressSocial circumstances | 1/8 |
| Age, Categorical(Participants) | Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 36 ± 11 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 7 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Intervention |
|---|---|
| White British | 4 |
| Caribbean | 1 |
| Black/Black British/Caribbean | 1 |
| Mixed Ethnicity | 1 |
| White European | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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University of Manchester