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Specific PhobiaNCT03208400

Virtual Reality Exposure in Spider Phobia

A study testing virtual reality exposure in people with Specific Phobia and Cognitive-behavioral Therapy, run by Julius-Maximilians University at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
virtual reality exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
2 sitesGermany
Study dates
1 Sep 2017to 10 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Dept. of Psychiatry, University Hospital Münster

    Münster, North Rhine-Westphalia, 48149

  • Center of Mental Health, Dept. of Psychiatry, Psychosomatics, and Psychiatry, University Hospital of Wuerzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

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

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.

Being tested
virtual reality exposure
Medical subject headings
Phobia, Specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual reality exposureBehavioural

    one-session exposure conveyed via virtual reality technology

Study groups in NCT03208400
Study groupRoleWhat they receive
virtual reality exposureOtherone-session exposure conveyed via virtual reality technology
Receives: Behavioral: virtual reality exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spider Phobia Questionnaire (SPQ)

    Change in spider phobia symptoms before (baseline) to after therapy

    Measured: 4 weeks

Secondary outcomes (5)

  1. Behavioral Avoidance Text (BAT)

    Change (in cm) in the extend to which a living spider can be approached from before to after therapy

    Measured: 4 weeks

  2. 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

    Measured: 6 months

  3. Clinical Global Impressions (CGI)

    Clinician rated symptom severity after completion of treatment (4 weeks)

    Measured: 4 weeks

  4. Clinical Global Impressions (CGI)

    Clinician rated symptom severity after 6 month follow-up period

    Measured: 6 month

  5. Spider Phobia Questionnaire (SPQ)

    Change in spider phobia symptoms before (baseline) vs. after 6 month follow-up period

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start1 Sep 2017
  3. Primary completion31 May 2019
  4. Study completion10 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03208400
Sponsor's protocol ID
Spider_VR
Status last verified
Feb 2020
First submitted
28 Jun 2017
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarzmeier H, Leehr EJ, Bohnlein J, Seeger FR, Roesmann K, Gathmann B, Herrmann MJ, Siminski N, Junghofer 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. 2020 Jun;29(2):e1812. doi: 10.1002/mpr.1812. Epub 2019 Dec 8.

    PubMed 31814209

  • Chavanne AV, Meinke C, Langhammer T, Roesmann K, Boehnlein J, Gathmann B, Herrmann MJ, Junghoefer M, Klahn L, Schwarzmeier H, Seeger FR, Siminski N, Straube T, Dannlowski U, Lueken U, Leehr EJ, Hilbert K. Individual-Level Prediction of Exposure Therapy Outcome Using Structural and Functional MRI Data in Spider Phobia: A Machine-Learning Study. Depress Anxiety. 2023 Aug 22;2023:8594273. doi: 10.1155/2023/8594273. eCollection 2023.

    PubMed 40224607

  • Langhammer T, Hilbert K, Adolph D, Arolt V, Bischoff S, Bohnlein J, Cwik JC, Dannlowski U, Deckert J, Domschke K, Evens R, Fydrich T, Gathmann B, Hamm AO, Heinig I, Herrmann MJ, Hollandt M, Junghoefer M, Kircher T, Koelkebeck K, Leehr EJ, Lotze M, Margraf J, Mumm JLM, Pittig A, Plag J, Richter J, Roesmann K, Ridderbusch IC, Schneider S, Schwarzmeier H, Seeger F, Siminski N, Straube T, Strohle A, Szeska C, Wittchen HU, Wroblewski A, Yang Y, Straube B, Lueken U. Resting-state functional connectivity in anxiety disorders: a multicenter fMRI study. Mol Psychiatry. 2025 Apr;30(4):1548-1557. doi: 10.1038/s41380-024-02768-2. Epub 2024 Oct 4.

    PubMed 39367057

  • Roesmann K, Leehr EJ, Bohnlein J, Gathmann B, Herrmann MJ, Junghofer M, Schwarzmeier H, Seeger FR, Siminski N, Straube T, Dannlowski U, Lueken U. Mechanisms of action underlying virtual reality exposure treatment in spider phobia: Pivotal role of within-session fear reduction. J Anxiety Disord. 2023 Dec;100:102790. doi: 10.1016/j.janxdis.2023.102790. Epub 2023 Oct 14.

    PubMed 37879242

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality exposure in people with Specific Phobia and Cognitive-behavioral Therapy, run by Julius-Maximilians University at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spider Phobia Questionnaire (SPQ) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208400, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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Virtual Reality Exposure in Spider Phobia | AzTrials