Virtual Reality Exposure in Spider Phobia
Study Details
Study Description
Brief Summary
While knowledge on the neurobiological signatures of fear and anxiety disorders and, in particular, their association with treatment outcome is accumulating, clinical translation still awaits empirical proof of evidence. Exposure-based cognitive-behavioral therapy (CBT) is a first-line treatment, but clinically significant change is only seen in approx. 50-65% of patients. Patient stratification is a powerful option to increase treatment response; however, developing prognostic markers suitable for single-patient predictions still is in its infancy and crucially requires external cross-validation embedded within an a priori prediction approach - a procedure yet largely missing in the field of biomarker research. Employing a bicentric strategy the aim of this study is to test the hypothesis that a priori prediction of treatment outcome based on neurobiological measures is possible in a second, independent sample. Building upon findings from previous mechanistic studies, These will be incorporated into the development of a predictive pattern comprising fear-relevant genotypes and molecules targeting neuropeptides, related epigenetic signatures as well as neurofunctional activation patterns associated with fear circuitry functions, and clinical data. Pre-treatment neurobiological signatures will be tested for their potential as a predictive response marker towards behavioral exposure (virtual reality exposure treatment (VRET) and an in vivo behavioral avoidance test) in a model disorder of fear circuitry dysfunctions (spider phobia). Multivariate pattern analyses employing a machine learning framework will be used to generate predictions on the individual patient level and to cross-validate markers in a second, independent sample. While at site A predictions will be generated following completion of the treatment, response will be predicted at site B a priori, but in a double-blind manner. Comparison of observed vs. predicted response rates will serve as a test of hypothesis. In addition, neuroplastic (on a subsample) and epigenetic changes induced by VRET treatment will be assessed following treatment and, in case of epigenetics, also after 6-months follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: virtual reality exposure one-session exposure conveyed via virtual reality technology |
Behavioral: virtual reality exposure
one-session exposure conveyed via virtual reality technology
|
Outcome Measures
Primary Outcome Measures
- Spider Phobia Questionnaire (SPQ) [4 weeks]
Change in spider phobia symptoms before (baseline) to after therapy
Secondary Outcome Measures
- Behavioral Avoidance Text (BAT) [4 weeks]
Change (in cm) in the extend to which a living spider can be approached from before to after therapy
- Behavioral Avoidance Text (BAT) [6 months]
Change (in cm) in the extend to which a living spider can be approached from before vs. after 6 month follow-up period
- Clinical Global Impressions (CGI) [4 weeks]
Clinician rated symptom severity after completion of treatment (4 weeks)
- Clinical Global Impressions (CGI) [6 month]
Clinician rated symptom severity after 6 month follow-up period
- Spider Phobia Questionnaire (SPQ) [6 months]
Change in spider phobia symptoms before (baseline) vs. after 6 month follow-up period
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 or older
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specific phobia (animal subtype: spider phobia) according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-5)
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right-handedness
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Caucasian descent
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willingness to participate in massed exposure
Exclusion Criteria:
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patients exhibiting a primary other anxiety disorder (panic disorder, agoraphobia, social phobia, generalized anxiety disorder), acute suicidality, psychotic, bipolar I, obsessive-compulsive disorder, posttraumatic stress disorder, severe major depression, borderline personality disorder or substance dependency (except nicotine)
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patients fulfilling MRI-related exclusion criteria
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patients with current pharmacological or psychotherapeutic treatment, as well as those already previously treated with exposure-based CBT
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pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center of Mental Health, Dept. of Psychiatry, Psychosomatics, and Psychiatry, University Hospital of Wuerzburg | Wuerzburg | Bavaria | Germany | 97080 |
| 2 | Dept. of Psychiatry, University Hospital Münster | Münster | North Rhine-Westphalia | Germany | 48149 |
Sponsors and Collaborators
- Julius-Maximilians University
- University Hospital Muenster
Investigators
- Principal Investigator: Ulrike Lueken, Prof. Dr., University Hospital of Wuerzburg
Study Documents (Full-Text)
None provided.More Information
Publications
- Spider_VR