- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432945
In Vivo Exposure vs. Videochat-Based Vicarious Exposure
Comparison of Exposure Trainings for Spider Phobia (German Title: Vergleich Von Expositionstrainings für Spinnenangst)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exposure therapy is an effective treatment for phobic fears and anxiety disorders that is considered in treatment guidelines as a first-choice treatment for e.g. specific phobia. However, many anxiety patients do not receive exposure therapy due to practical barriers (time, spaces, practitioner capacities) and reportedly negative treatment expectations of many clinicians. Previous studies on fear extinction and vicarious exposure suggest vicarious learning as a mechanism for treatment of anxiety. One central mechanism of exposure is fear extinction. Interestingly, fear extinction can be induced by the mere observation of videos of non-fearful individuals reacting placidly to a feared stimulus. The extent to which vicarious fear extinction is transferrable to an exposure context remains elusive. Previous studies on vicarious exposure yielded promising results, including a study on long-term effects. After a comparison of videochat based vicarious exposure therapy (VicET) with in-vivo exposure (IVET), the investigators will examine fear and disgust reactions. Further, the investigators will examine fear and disgust generalization. To the best of our knowledge, no study has considered generalization and disgust extinction in a comparison of in-vivo exposure (IVET) with vicarious exposure therapy (VicET) in a controlled laboratory setting. Furthermore, our study proposes a new approach of implementing vicarious exposure therapy as participants observe a spider phobia treatment via videochat. VicET yields potential to surpass aversive components of IVET which may have caused IVET to be more stress-inducing to patients and less acceptable to clinicians. Further, videochat based VicET might be expandable to treatment groups and patients held back by physical barriers, posing a potentially cost-effective treatment for e.g. waitlist patients.
The investigators hypothesize that both treatment groups (IVET & VicET) will perform better than the waiting list control (WLC) group (indicated by stronger reductions in spider fear & avoidance measures, namely increased BAT steps, reduction in heart rate & SUDS fear ratings). The investigators further expect that IVET & VicET will exhibit similar treatment gains (reduction in subjective fear, increase in behavioral approach and decreased heart rate in the BAT), leading to no significant differences in spider fear & avoidance measures. It is predicted that generalization is effective in both the IVET and the VicET group (indicated by a reduction of fear & avoidance measures from Pre-Generalization-BAT to Post-Generalization-BAT). Therefore, the investigators expect the WLC group to exhibit smaller symptom improvements in all BAT measures to the nontreated spider. Given the absence of previous studies examining disgust generalization, no specific hypotheses can be drawn. The investigators expect no differences in measures of spider fear between IVET & VicET at follow-up, with the WLC group exhibiting higher levels of spider fear.
Further analyses will be conducted to investigate possible differences in IVET & VicET regarding subjective fear during treatment (on a behavioral, subjective and psychophysiological level), disgust, self efficacy & generalization. Questionnaires used in these analyses are listed as other outcome measures. An unexpected memory test will be inserted at post assessment to allow for investigation of memory for treatment experiences made during exposure therapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan A Heistermann, M.Sc.
- Phone Number: (+49)02343228469
- Email: Jan.Heistermann@ruhr-uni-bochum.de
Study Locations
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Bochum, Germany
- Recruiting
- Behavioral and Clinical Neuroscience
-
Contact:
- Jan A Heistermann, M.Sc.
- Phone Number: (+49)02343228469
- Email: Jan.Heistermann@ruhr-uni-bochum.de
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of fear of spiders (Potential diagnosis of arachnophobia)
Exclusion Criteria:
- Reaching level 10 or higher in initial BATs
- Any acute or chronic mental disease more debilitating than fear of spiders
- Any debilitating acute or chronic somatic disease that prevents or counteracts exposure treatment effects (such as cardiovascular diseases)
- Heart Diseases (Pace makers, Bradycardia, Arterial Hypertonia, Heart Arrhythmia)
- Psychological, psychiatric, neurological or pharmacological treatment
- Drug or alcohol abuse
- Pregnancy
- Insect Sting Allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: In Vivo Exposure (IVET)
Participants are subjected to a pre-assessment (questionnaires and BATs with treated spider and non-treated spider) and an in-vivo exposure, exposing them to the treated spider by approaching it in a predetermined sequence of steps.
For further analyses, subjective fear, subjective disgust & heart rate are measured during treatment.
Post assessment consists of two BATs (treated spider and non-treated spider) and questionnaires.
An online follow-up consists of brief questionnaires.
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One session of graded in-vivo exposure with the treated spider.
Prior to the exposure, participants receive psychoeducation on spiders, exposure therapy and specific phobia.
Other Names:
|
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Experimental: Vicarious Exposure (VicET)
Participants are set to receive a pre-assessment (questionnaires and BATs with treated spider and non-treated spider) and a vicarious exposure, exposing them to the treated spider by watching the experimenter approach it in a predetermined sequence of step (same as IVET) via two cameras.
For further analyses, subjective fear, subjective disgust & heart rate are measured during treatment.
Post assessment consists of two BATs (treated spider and non-treated spider) and questionnaires.
An online follow-up consists of brief questionnaires.
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One session of graded video-based vicarious exposure with the treated spider.
The steps are modeled by the experimenter.
Prior to the exposure, participants receive psychoeducation on spiders, exposure therapy and specific phobia.
Other Names:
|
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No Intervention: Waitinglist Control (WLC)
Participants are set to receive a pre-assessment (questionnaires and BATs with treated spider and non-treated spider).
Subsequent post-assessment consists of two BATs (treated spider and non-treated spider) and questionnaires.
An online follow-up consists of brief questionnaires.
Participants receive a session of IVET after assessment is completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Approach Test (BAT)
Time Frame: Pre-Assessment (immediately prior to exposure for the IVET & VicET groups, which corresponds to the end of first assessment day for the WLC group as they receive exposure at the end of the study), Post-Assessment (the next day).
|
Change in the Behavioral Approach Tests (BAT) from pre- to post-assessment.
BATs are conducted with both the treated spider and the non-treated spider.
In the Behavioral Approach Test (BAT) the closest distance that a participant approached the spider is measured (final approach distance).
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Pre-Assessment (immediately prior to exposure for the IVET & VicET groups, which corresponds to the end of first assessment day for the WLC group as they receive exposure at the end of the study), Post-Assessment (the next day).
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Subjective fear
Time Frame: At Pre-Assessment (during BATs, Day 1 & treatments), At Post-Assessment (during BATs, Day 2)
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Change in subjective fear from pre- to post-assessment is measured regarding the treated spider and the non-treated spider (SUDS scale during pre-assessment and post-assessment BATs).
A comparison of the SUDS at the final approach distance at pre-assessment with the SUDS at the same distance at post-assessment (so called "initial approach") allows for an estimate of subjective fear reduction.
Additionally, the change in subjective fear at the final approach distance from pre- to post-assessment can be observed.
SUDS are measured on a scale from 0 (no fear) to 100 (highest possible fear).
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At Pre-Assessment (during BATs, Day 1 & treatments), At Post-Assessment (during BATs, Day 2)
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Subjective disgust
Time Frame: Pre-Assessment (during BATs & treatments), Post-Assessment (during BATs)
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Change in subjective disgust from pre- to post-assessment is measured regarding the treated spider and the non-treated spider (SUDS scale during Pre-assessment and Post-assessment BAT).
A comparison of the SUDS at the final approach distance at pre-assessment with the SUDS at the same distance at post-assessment (so called "initial approach") allows for an estimate of subjective disgust reduction.
Additionally, the change in subjective disgust at the final approach distance from pre- to post-assessment can be observed.
SUDS are measured on a scale from 0 (no disgust) to 100 (highest possible disgust).
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Pre-Assessment (during BATs & treatments), Post-Assessment (during BATs)
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Heart Rate
Time Frame: Pre-Assessment (during BATs) & Post-Assessment (during BATs). Measured throughout all of Pre-Assessment (including 5-minute resting heartrate measurement), all of Post-Assessment (including 5-minute resting heartrate measurement) & Treatment.
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Change in mean heart rate from pre- to post-assessment BAT with treated spider and non-treated spider.
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Pre-Assessment (during BATs) & Post-Assessment (during BATs). Measured throughout all of Pre-Assessment (including 5-minute resting heartrate measurement), all of Post-Assessment (including 5-minute resting heartrate measurement) & Treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear of Spiders Questionnaire (FSQ; german: FAS)
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Scores of spider fear ranging from 0 to 108 (sum), with higher scores indicative of greater fear.
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Spider Beliefs Questionnaire (SBQ)
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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The questionnaire consists of 48 statements of phobia related beliefs.
Subjects are asked to rate how much they agree to the statements.
Higher scores are indicative of greater fear.
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specific Phobia Questionnaire (SPQ)
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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A modified version of the SPQ.
The SPQ consists of two dimensions (fear & interference with life).
45 items are rated ("none", "mild", "moderate", "severe", "extreme") on both dimensions.
For the present study, we employed the fear subscale and dropped the interference scale.
The fear scale was split up into fear and avoidance.
This questionnaire allows for an estimate the overall fear and avoidance of 43 potentially phobic situations (+2 "other" options) and a composite score of each of the five phobia subtypes.
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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General Self-Efficacy (GSE) Scale
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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The GSE is employed to measure changes in self-efficacy.
It consists of ten items that evaluate the participants' confidence in their ability to overcome difficult situations based on their self-reported competence.
A sum score of all items is calculated (ranging from 10 to 40).
Higher scores are indicative of a higher general self-efficacy.
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Self-Efficacy Questionnaire for Phobic Situations (SEQ-SP)
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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The SEQ-SP is a 13 item questionnaire on specific animal-related phobic situations, assessing self-efficacy expectations on a five-point scale ranging from one (really sure I couldn't) to 5 (really sure I could).
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Questionnaire for the Assessment of Disgust Sensitivity (German: Fragebogen zur Erfassung der Ekelempfindlichkeit (FEE))
Time Frame: Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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The FEE is a 37-item questionnaire.
It comprises of different situations that might elicit disgust, rated from "not disgusting" to "very disgusting" on a 5-point scale.
The FEE is included as a measure of disgust sensitivity, as research points towards relevance of disgust sensitivity in the acquisition and maintenance of anxiety disorders (Schienle et al., 2002).
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Prior to the Pre-Assessment BATs (Day 1), after Post-Assessment BATs (Day 2, 24 hours later) and at Follow-Up (approx. 6 weeks after Day 2).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Armin Zlomuzica, Prof. Dr., Ruhr University of Bochum
Publications and helpful links
General Publications
- Zlomuzica, A., Raeder, F., Reher, S., Lange, M., & Dere, E. (2025). Context-dependency of vicarious extinction learning. Behavioural Brain Research, 482, 115461. https://doi.org/10.1016/j.bbr.2025.115461
- Gilroy, L. J., Kirkby, K. C., Daniels, B. A., Menzies, R. G., & Montgomery, I. M. (2000). Controlled comparison of computer-aided vicarious exposure versus live exposure in the treatment of spider phobia. Behavior Therapy, 31(4), 733-744. https://doi.org/10.1016/S0005-7894(00)80041-6
- Rinck, M., Bundschuh, S., Engler, S., Müller, A., Wissmann, J., Ellwart, T., & Becker, E. S. (2002). Reliabilität und Validität dreier Instrumente zur Messung von Angst vor Spinnen. [Reliability and validity of German versions of three instruments measuring fear of spiders.]. Diagnostica, 48(3), 141-149. https://doi.org/10.1026//0012-1924.48.3.141
- Szymanski, J., & O'Donohue, W. (1995). Fear of spiders questionnaire. Journal of behavior therapy and experimental psychiatry, 26(1), 31-34.
- Schienle, A., Walter, B., Stark, R., & Vaitl, D. (2002). Ein Fragebogen zur Erfassung der Ekelempfindlichkeit (FEE). Zeitschrift für Klinische Psychologie und Psychotherapie, 31(2), 110-120. https://doi.org/10.1026/0084-5345.31.2.110
- Rosen, L. D., Whaling, K., Carrier, L. M., Cheever, N. A., & Rokkum, J. (2013). The Media and Technology Usage and Attitudes Scale: An empirical investigation. Computers in Human Behavior, 29(6), 2501-2511. https://doi.org/10.1016/j.chb.2013.06.006
- Pössel, P., & Hautzinger, M. (2003). Dysfunktionale Überzeugungen bei Spinnenangst. Zeitschrift für Klinische Psychologie und Psychotherapie, 32(1), 24-30. https://doi.org/10.1026/0084-5345.32.1.24
- Ovanessian, M. M., Fairbrother, N., Vorstenbosch, V., McCabe, R. E., Rowa, K., & Antony, M. M. (2019). Psychometric Properties and Clinical Utility of the Specific Phobia Questionnaire in an Anxiety Disorders Sample. Journal of Psychopathology and Behavioral Assessment, 41(1), 36-52. https://doi.org/10.1007/s10862-018-9687-1
- Laux, L., Glanzmann, P., Schaffner, P., & Spielberger, C. D. (1981). State-Trait-Angstinventar (STAI). Beltz.
- Jerusalem, M., & Schwarzer, R. (1999). Skala zur Allgemeinen Selbstwirksamkeitserwartung (SWE). In Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen.
- Gilroy, L. J., Kirkby, K. C., Daniels, B. A., Menzies, R. G., & Montgomery, I. M. (2003). Long-term follow-up of computer-aided vicarious exposure versus live graded exposure in the treatment of spider phobia. Behavior Therapy, 34(1), 65-76. https://doi.org/10.1016/S0005-7894(03)80022-9
- Flatt, N., & King, N. (2009). The Self-Efficacy Questionnaire for Phobic Situations (SEQ-SP): Development and Psychometric Evaluation. Behaviour Change, 26(2), 141-152. https://doi.org/10.1375/bech.26.2.141
- Borkovec, T. D., & Nau, S. D. (1972). Credibility of Analogue Therapy Rationales. Journal of Behavior Therapy and Experimental Psychiatry, 3(4), 257-260. https://doi.org/10.1016/0005-7916(72)90045-6
- Beck, A. T., Keller, F., & Kühner, C. (2006). Beck Depressions-Inventar: BDI II.Revision [Testmaterial]. Harcourt Test Services.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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