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The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.
This is a treatment development trial, participants randomly assigned to active treatment will be enrolled in embodied Virtual Reality therapy. The therapy will be based on principals of exposure and behavioral shaping therapies and mirror visual feedback therapy. The therapy will be delivered over 8 sessions and modified as indicated by clinical feedback. A fixed protocol will be developed with exact methods to be used to be determined. After a fixed protocol has been established, a treatment manual will be created to use in further controlled trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Therapy | Experimental | Eight 30 minute sessions of embodied virtual reality therapy with use of a body transfer experience into an egocentric perspective avatar that encourages motor activity and desensitization to emotional cues. |
|
| Control | Active Comparator | Eight 30 minute sessions of virtual reality therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embodied Virtual Reality Therapy | Other | Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways and involves body tracking and controlled sensory feedback reinforcing movement in real and virtual time by immersive head mounted displays. This game will have subjects fully embody and inhabit an avatar from an egocentric perspective. In addition, over consecutive sessions subjects will be asked to use a mobile smart phone based virtual reality program designed to deliver various and customized emotionally provocative stimuli. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Number of sessions attended over 12 weeks recorded by therapist | Number of sessions attended over 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| General Self-Efficacy Scale | self-report | baseline, biweekly for 6weeks, then 6,9,12 months |
| Global Assessment of Functioning (GAF) | physician administered Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim D Bullock, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31687867 | Result | Bullock K, Won AS, Bailenson J, Friedman R. Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy for FND: A Midpoint Report of a Randomized Controlled Feasibility Study. J Neuropsychiatry Clin Neurosci. 2020 Winter;32(1):90-94. doi: 10.1176/appi.neuropsych.19030071. Epub 2019 Nov 5. |
| Label | URL |
|---|---|
| Midway point results | View source |
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Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
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|
| Virtual reality | Other | Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways. |
|
| baseline, 6weeks, then 6,9,12 months |
| Generalized Anxiety Disorder 7-item (GAD-7) scale | A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD) | baseline, biweekly for 6weeks then 6,9,12 months |
| Patient Health Questionnaire-9 (PHQ-9) | self-report | baseline, biweekly for 6weeks then 6,9,12 months |
| Oxford Handicap Scale | physician administered | baseline, 6weeks, then 6,9,12 months |
| Frequency and severity of functional symptoms | self-report weekly log format | baseline, biweekly for 6 weeks then 6,9,12 months |
| Frequency of adverse events | physician and subject report | baseline, biweekly for 6 weeks then 6,9,12 months |
| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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