NCT02973919

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

November 14, 2016

Last Update Submit

November 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Skin Conductance Reactivity (SCR)

    during the VR-session

  • Electrocardiogram (ECG)

    during the VR-session

  • manipulation check electrode below the right eye (M. orbicularis oculi)

    during the VR- exposure sessions (5 min x 4 sessions)

  • Change in Subjective Fear Ratings

    1 min before and during ( each minute) exposure in Virtual Reality

Study Arms (2)

Eye movements

EXPERIMENTAL

Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy

Behavioral: Eye Movement Desensitization and Reprocessing TherapyBehavioral: Virtual Reality Exposure Therapy

Control

ACTIVE COMPARATOR

virtual reality exposure therapy

Behavioral: Virtual Reality Exposure Therapy

Interventions

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).

Eye movements

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).

ControlEye movements

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • current psychopharmacological medication
  • current involvement in psychiatric- or psychotherapeutic treatment
  • cardiovascular or neurological diseases
  • color blindness
  • hearing disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arachnophobia

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 28, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

September 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share