EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome

Sponsor

University of Regensburg (Other)

Overall Status

Completed

CT.gov ID

NCT02973919

Collaborator

(none)

Enrollment

Arms

14.1

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spider Phobia	Behavioral: Eye Movement Desensitization and Reprocessing Therapy Behavioral: Virtual Reality Exposure Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eye movements Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy	Behavioral: Eye Movement Desensitization and Reprocessing 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). Behavioral: 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).
Active Comparator: Control virtual reality exposure therapy	Behavioral: 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).

Arm

Intervention/Treatment

Experimental: Eye movements

Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy

Behavioral: Eye Movement Desensitization and Reprocessing 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).

Behavioral: 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).

Active Comparator: Control

virtual reality exposure therapy

Behavioral: Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcome Measures

Change in Behavioral Assessment Test (BAT) in vivo [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

Secondary Outcome Measures

Skin Conductance Reactivity (SCR) [during the VR-session]
Electrocardiogram (ECG) [during the VR-session]
providing the Heart Rate (HR)
manipulation check electrode below the right eye (M. orbicularis oculi) [during the VR- exposure sessions (5 min x 4 sessions)]
for registering eye movements
Change in Subjective Fear Ratings [1 min before and during ( each minute) exposure in Virtual Reality]
Subjective Units of Disturbance Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Regensburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shiban Youssef, Phd, University of Regensburg

ClinicalTrials.gov Identifier:

NCT02973919

Other Study ID Numbers:

URegensburg

First Posted:

Nov 28, 2016

Last Update Posted:

Nov 28, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Phobic Disorders

Study Results

No Results Posted as of Nov 28, 2016