- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973919
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
The goal of this study is to increase the efficiency of exposure in virtual reality (VR).
Based on the EMDR research the investigators would like to show that the implementation of eye movements during the VR exposure results in a faster physiological relaxation response among probands with spider phobia, which has a positive effect on the subjective and behavioral efficacy of the VR exposure.
Study Overview
Status
Conditions
Detailed Description
The VR paradigm consists of one room with a spider in it. The proband is supposed to look at it for a few minutes. This exposure is repeated several times.
In the experimental group a ball appears during the exposure, that moves horizontally across the room. The probands are supposed to follow this movement with their eyes.
EDA, EKG and respiration are being recorded. Furthermore the subjective and behavioral spider phobia is measured before, during and after the exposure to determine occurring changes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the Structured Clinical Interview for DSM-IV (SCID, First et al., 2002; applied German translation: Strukturiertes Klinisches Interview für DSM-IV, Achse I, SKID I, Wittchen et al., 1997), in order to get a reliable diagnosis of spider phobia
Exclusion Criteria:
- pregnancy
- current psychopharmacological medication
- current involvement in psychiatric- or psychotherapeutic treatment
- cardiovascular or neurological diseases
- color blindness
- hearing disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Eye movements
Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy
|
In 1989, Shapiro discovered that while talking about negative life events or thoughts, rhythmic eye movements on a horizontal axis can alleviate the associated vividness and burden (Shapiro, 1989).
She established the psychodynamic-behavioral Eye Movement Desensitization and Reprocessing (EMDR) Therapy, which includes the induction of rhythmic eye movements as a central feature.
EMDR is regarded as an efficient treatment tool.
Several times it has also been successfully applied in the field of specific phobias (de Jongh, ten Broeke, & Renssen, 1999; de Jongh, Holmshaw, Carswell, & van Wijk, 2011; Lapsekili & Yelboga, 2014; Muris, Merckelbach, van Haaften, & Mayer, 1997) and there is a standard protocol for using EMDR on specific fears and phobias (de Jongh, 2015).
Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET).
One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators.
Feared stimuli or scenarios can be varied on individual purposes and presented several times.
This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g.
being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger & Pauli, 2011).
|
ACTIVE_COMPARATOR: Control
virtual reality exposure therapy
|
Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET).
One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators.
Feared stimuli or scenarios can be varied on individual purposes and presented several times.
This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g.
being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger & Pauli, 2011).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Assessment Test (BAT) in vivo
Time Frame: 5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
|
expected fear just before getting started and actually present fear just before finishing
|
5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Conductance Reactivity (SCR)
Time Frame: during the VR-session
|
during the VR-session
|
|
Electrocardiogram (ECG)
Time Frame: during the VR-session
|
providing the Heart Rate (HR)
|
during the VR-session
|
manipulation check electrode below the right eye (M. orbicularis oculi)
Time Frame: during the VR- exposure sessions (5 min x 4 sessions)
|
for registering eye movements
|
during the VR- exposure sessions (5 min x 4 sessions)
|
Change in Subjective Fear Ratings
Time Frame: 1 min before and during ( each minute) exposure in Virtual Reality
|
Subjective Units of Disturbance Scale
|
1 min before and during ( each minute) exposure in Virtual Reality
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URegensburg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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