Clinical Trial: Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Stanford University

Current Primary Outcome: Adherence [ Time Frame: Number of sessions attended over 12 weeks ]

Number of sessions attended over 12 weeks recorded by therapist


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • General Self-Efficacy Scale [ Time Frame: baseline, biweekly for 6weeks, then 6,9,12 months ]
    self-report
  • Global Assessment of Functioning (GAF) [ Time Frame: baseline, 6weeks, then 6,9,12 months ]
    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
  • Generalized Anxiety Disorder 7-item (GAD-7) scale [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]
    A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD)
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]
    self-report
  • Oxford Handicap Scale [ Time Frame: baseline, 6weeks, then 6,9,12 months ]
    physician administered
  • Frequency and severity of functional symptoms [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]
    self-report weekly log format
  • Frequency of adverse events [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]
    physician and subject report


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: May 2, 2016
Date Started: May 2016
Date Completion: January 2020
Last Updated: February 19, 2017
Last Verified: February 2017