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Virtual Reality Exposure in Spider Phobia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208400
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
University Hospital Muenster
Information provided by (Responsible Party):
Ulrike Lueken, 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.

Condition or disease Intervention/treatment Phase
Specific Phobia Cognitive-behavioral Therapy Virtual Reality Behavioral: virtual reality exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exposure Treatment in Anxiety Disorders: Proof of Principle for an a Priori Response Prediction Approach
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

Arm Intervention/treatment
virtual reality exposure
one-session exposure conveyed via virtual reality technology
Behavioral: virtual reality exposure
one-session exposure conveyed via virtual reality technology




Primary Outcome Measures :
  1. Spider Phobia Questionnaire (SPQ) [ Time Frame: 4 weeks ]
    Change in spider phobia symptoms before (baseline) to after therapy


Secondary Outcome Measures :
  1. Behavioral Avoidance Text (BAT) [ Time Frame: 4 weeks ]
    Change (in cm) in the extend to which a living spider can be approached from before to after therapy

  2. Behavioral Avoidance Text (BAT) [ Time Frame: 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

  3. Clinical Global Impressions (CGI) [ Time Frame: 4 weeks ]
    Clinician rated symptom severity after completion of treatment (4 weeks)

  4. Clinical Global Impressions (CGI) [ Time Frame: 6 month ]
    Clinician rated symptom severity after 6 month follow-up period

  5. Spider Phobia Questionnaire (SPQ) [ Time Frame: 6 months ]
    Change in spider phobia symptoms before (baseline) vs. after 6 month follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208400


Locations
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Germany
Center of Mental Health, Dept. of Psychiatry, Psychosomatics, and Psychiatry, University Hospital of Wuerzburg
Wuerzburg, Bavaria, Germany, 97080
Dept. of Psychiatry, University Hospital Münster
Münster, North Rhine-Westphalia, Germany, 48149
Sponsors and Collaborators
Julius-Maximilians University
University Hospital Muenster
Investigators
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Principal Investigator: Ulrike Lueken, Prof. Dr. University Hospital of Wuerzburg
Publications:
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Responsible Party: Ulrike Lueken, Prof. Dr., Julius-Maximilians University
ClinicalTrials.gov Identifier: NCT03208400    
Other Study ID Numbers: Spider_VR
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders