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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
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spider Phobia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

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

    First Posted
    November 14, 2016
    Last Updated
    November 21, 2016
    Sponsor
    University of Regensburg
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    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

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