EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Primary Purpose
Spider Phobia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing Therapy
Virtual Reality Exposure Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Spider Phobia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eye movements
Control
Arm Description
Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy
virtual reality exposure therapy
Outcomes
Primary Outcome Measures
Change in Behavioral Assessment Test (BAT) in vivo
expected fear just before getting started and actually present fear just before finishing
Secondary Outcome Measures
Skin Conductance Reactivity (SCR)
Electrocardiogram (ECG)
providing the Heart Rate (HR)
manipulation check electrode below the right eye (M. orbicularis oculi)
for registering eye movements
Change in Subjective Fear Ratings
Subjective Units of Disturbance Scale
Full Information
NCT ID
NCT02973919
First Posted
November 14, 2016
Last Updated
November 21, 2016
Sponsor
University of Regensburg
1. Study Identification
Unique Protocol Identification Number
NCT02973919
Brief Title
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Official Title
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spider Phobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eye movements
Arm Type
Experimental
Arm Description
Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
virtual reality exposure therapy
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Behavioral Assessment Test (BAT) in vivo
Description
expected fear just before getting started and actually present fear just before finishing
Time Frame
5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
Secondary Outcome Measure Information:
Title
Skin Conductance Reactivity (SCR)
Time Frame
during the VR-session
Title
Electrocardiogram (ECG)
Description
providing the Heart Rate (HR)
Time Frame
during the VR-session
Title
manipulation check electrode below the right eye (M. orbicularis oculi)
Description
for registering eye movements
Time Frame
during the VR- exposure sessions (5 min x 4 sessions)
Title
Change in Subjective Fear Ratings
Description
Subjective Units of Disturbance Scale
Time Frame
1 min before and during ( each minute) exposure in Virtual Reality
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
We'll reach out to this number within 24 hrs