Spider PhobiaNCT02973919
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
A study testing Eye Movement Desensitization and Reprocessing Therapy and Virtual Reality Exposure Therapy in people with Spider Phobia, run by University of Regensburg.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Spider Phobia
- What is being tested?
- Eye Movement Desensitization and Reprocessing Therapy and Virtual Reality Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- current psychopharmacological medication
- current involvement in psychiatric- or psychotherapeutic treatment
- cardiovascular or neurological diseases
- color blindness
- hearing disorders
About this study
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.
Read the 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.
- Conditions
- Spider Phobia
- Being tested
- Eye Movement Desensitization and Reprocessing Therapy, Virtual Reality Exposure Therapy
- Medical subject headings
- Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing TherapyBehavioural
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 TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Eye movements | Experimental | Eye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy Receives: Behavioral: Eye Movement Desensitization and Reprocessing Therapy; Behavioral: Virtual Reality Exposure Therapy |
| Control | Active comparator | virtual reality exposure therapy Receives: Behavioral: Virtual Reality Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Assessment Test (BAT) in vivo
expected fear just before getting started and actually present fear just before finishing
Measured: 5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
Secondary outcomes (4)
Skin Conductance Reactivity (SCR)
Measured: during the VR-session
Electrocardiogram (ECG)
providing the Heart Rate (HR)
Measured: during the VR-session
manipulation check electrode below the right eye (M. orbicularis oculi)
for registering eye movements
Measured: during the VR- exposure sessions (5 min x 4 sessions)
Change in Subjective Fear Ratings
Subjective Units of Disturbance Scale
Measured: 1 min before and during ( each minute) exposure in Virtual Reality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spider PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiban Youssef, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973919
- Sponsor's protocol ID
- URegensburg
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
- ClinicalTrials.gov ID
- NCT02973919
- Acronym / sponsor ID
- URegensburg
- Conditions
- Spider Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye movements | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing Therapy, Behavioral: Virtual Reality Exposure TherapyEye Movement Desensitization and Reprocessing Therapy + virtual reality exposure therapy |
| Control | Active comparator | Behavioral: Virtual Reality Exposure Therapyvirtual reality exposure therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy
- current psychopharmacological medication
- current involvement in psychiatric- or psychotherapeutic treatment
- cardiovascular or neurological diseases
- color blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing TherapyIn 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). | Behavioural | Eye movements |
| Virtual Reality Exposure TherapyExposure 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). | Behavioural | Control, Eye movements |
Primary outcome
Change in Behavioral Assessment Test (BAT) in vivo
Time frame: 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
4 secondary outcomes
Skin Conductance Reactivity (SCR)
Time frame: during the VR-session
Electrocardiogram (ECG)
Time frame: during the VR-session
manipulation check electrode below the right eye (M. orbicularis oculi)
Time frame: during the VR- exposure sessions (5 min x 4 sessions)
Change in Subjective Fear Ratings
Time frame: 1 min before and during ( each minute) exposure in Virtual Reality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing Therapy and Virtual Reality Exposure Therapy in people with Spider Phobia, run by University of Regensburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Assessment Test (BAT) in vivo (time frame: 5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.