Virtual Reality Exposure in Spider Phobia

Virtual Reality Clinical Trial

Official title:

Exposure Treatment in Anxiety Disorders: Proof of Principle for an a Priori Response Prediction Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208400
• Other study ID #: Spider_VR
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2020
• Source: Julius-Maximilians University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: February 10, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive-behavioral Therapy
• Phobic Disorders
• Specific Phobia
• Virtual Reality

Intervention

Behavioral:
• virtual reality exposure
one-session exposure conveyed via virtual reality technology

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Julius-Maximilians University	University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schwarzmeier H, Leehr EJ, Böhnlein J, Seeger FR, Roesmann K, Gathmann B, Herrmann MJ, Siminski N, Junghöfer M, Straube T, Grotegerd D, Dannlowski U. Theranostic markers for personalized therapy of spider phobia: Methods of a bicentric external cross-validation machine learning approach. Int J Methods Psychiatr Res. 2019 Dec 8:e1812. doi: 10.1002/mpr.1812. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spider Phobia Questionnaire (SPQ)	Change in spider phobia symptoms before (baseline) to after therapy	4 weeks
Secondary	Behavioral Avoidance Text (BAT)	Change (in cm) in the extend to which a living spider can be approached from before to after therapy	4 weeks
Secondary	Behavioral Avoidance Text (BAT)	Change (in cm) in the extend to which a living spider can be approached from before vs. after 6 month follow-up period	6 months
Secondary	Clinical Global Impressions (CGI)	Clinician rated symptom severity after completion of treatment (4 weeks)	4 weeks
Secondary	Clinical Global Impressions (CGI)	Clinician rated symptom severity after 6 month follow-up period	6 month
Secondary	Spider Phobia Questionnaire (SPQ)	Change in spider phobia symptoms before (baseline) vs. after 6 month follow-up period	6 months