EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome

Spider Phobia Clinical Trial

Official title:

EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973919
• Other study ID #: URegensburg
• Status: Completed
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 21, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Spider Phobia

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behavioral Assessment Test (BAT) in vivo	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)	No
Secondary	Skin Conductance Reactivity (SCR)		during the VR-session	No
Secondary	Electrocardiogram (ECG)	providing the Heart Rate (HR)	during the VR-session	No
Secondary	manipulation check electrode below the right eye (M. orbicularis oculi)	for registering eye movements	during the VR- exposure sessions (5 min x 4 sessions)	No
Secondary	Change in Subjective Fear Ratings	Subjective Units of Disturbance Scale	1 min before and during ( each minute) exposure in Virtual Reality	No