Virtual Reality Exposure in Spider Phobia

Not Applicable

Completed

• Conditions: Specific Phobia; Virtual Reality; Cognitive-behavioral Therapy
• Interventions: Behavioral: virtual reality exposure

• Registration Number: NCT03208400
• Lead Sponsor: Julius-Maximilians University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Study Start: 2017-09-01
• Primary Completion: 2019-05-31
• Status Verified: 2020-02
• Study Completion: 2020-02-10
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• 18 or older
• specific phobia (animal subtype: spider phobia) according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-5)
• right-handedness
• Caucasian descent
• willingness to participate in massed exposure

Exclusion Criteria

• 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)
• patients fulfilling MRI-related exclusion criteria
• patients with current pharmacological or psychotherapeutic treatment, as well as those already previously treated with exposure-based CBT
• pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
virtual reality exposure	virtual reality exposure	one-session exposure conveyed via virtual reality technology

Primary Outcome Measures

Name	Time	Method
Spider Phobia Questionnaire (SPQ)	4 weeks	Change in spider phobia symptoms before (baseline) to after therapy

Secondary Outcome Measures

Name	Time	Method
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
Spider Phobia Questionnaire (SPQ)	6 months	Change in spider phobia symptoms before (baseline) vs. after 6 month follow-up period
Clinical Global Impressions (CGI)	6 month	Clinician rated symptom severity after 6 month follow-up period

Trial Locations

Locations (2)

Dept. of Psychiatry, University Hospital Münster; 🇩🇪 Münster, North Rhine-Westphalia, Germany

Center of Mental Health, Dept. of Psychiatry, Psychosomatics, and Psychiatry, University Hospital of Wuerzburg; 🇩🇪 Wuerzburg, Bavaria, Germany