Trial document




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  DRKS00008927

Trial Description

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Title


Development and evaluation of a virtual exposure therapy in a driving simulator for patients with driving phobia - A pilot study

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Trial Acronym

Driving phobia - SIM

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URL of the Trial

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Brief Summary in Lay Language

Drivers suffering from driving phobia due to a traffic accident or another critical event in traffic receive a weeklong psychotherapeutic treatment including virtual exposure sessions in a driving simulator. Finally, the treatment is evaluated by a driving test with a driving instructor in real traffic.

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Brief Summary in Scientific Language

The aim of this pilot study is to develop and to evaluate an intensive therapy with virtual exposition for drivers with driving phobia after a traffic accident or another critical event in traffic. The virtual exposition is conducted in a high fidelity driving simulator of the Wurzburg Institute of Traffic Sciences. A standardized manual developed by the Psychotherapeutic Outpatient Clinic of the University of Wurzburg is used for the conduction of the therapy. The therapy comprises an anamnesis, a medical investigation, two preparing psychotherapy sessions, five sessions in the driving simulator and two follow-up sessions. The evaluation is conducted with 14 patients with driving phobia (treatment vs. waiting group). Those patients who master defined driving exercises in real traffic with a driving instructor which they had rated to be unmanageable before the therapy are classified as treated successfully (Behavioral Avoidance Test). Furthermore it is tested if the virtual exposure can also reduce symptoms of depression and anxiety as well as deficiencies in concentration. In order to document and control the process of the therapy, cognitive, physiological and behavioral parameters are measured (i.e. anxiety ratings, heart rate, avoidance behavior). To further evaluate the success of the treatment, a booster session is conducted by phone six weeks after the treatment and a follow-up interview is conducted by phone twelve weeks after the treatment.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008927
  •   2015/11/02
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  •   yes
  •   Approved
  •   15077, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   F40.2 -  Specific (isolated) phobias
  •   F43.1 -  Post-traumatic stress disorder
  •   F43.2 -  Adjustment disorders
  •   driving phobia after traffic accident or another critical event in traffic
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Interventions/Observational Groups

  •   Experimental group receives an intensive behavioral therapy with a duration of one week including confrontation sessions in the driving simulator after a screening visit. 8 sessions - each lasting about 2 hours - are scheduled.
  •   Waiting group receives treatment with a delay of one week.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Avoidance behavior during the driving test in real traffic. The primary criterion is if the patients are able to master at least one driving task/situation in the driving test with a driving instructor, which they had rated before as not being manageable (or only with very strong anxiety). The decision for the success of the therapy is made by means of the rating of the driving instructor and of a traffic psychologist regarding the avoidance behavior (half-structured observation form).

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Secondary Outcome

• Driving behaviour during driving test with driving instructor (rating by the driving instructor, rating by the traffic psychologist by means of the semi-automatical application S.A.F.E. for tablet PCs)
• Subjective anxiety during the driving test with driving instructor as well as during the driving simulator sessions by means of the SUD-scale
• Pulse during the exposition sessions
• Concentration capability by means of the d2 Test of Attention (Brickenkamp et al., 2010) before and after the treatment
• Accident fear before the treatment and in the follow-up interview by means of the Accident Fear Questionnaire AFQ (Kuch et al., 1995)
• Symptoms of a posttraumatic stress disorder by means of the Posttraumatic Stress Scale Self-Report PSS-SR (Foa et al., 1997) before the treatment and in the follow-up interview
• Symptoms of anxiety disorders and depression before the treatment and in the follow-up interview by means of the Beck-Depression-Inventory II (BDI-II, Beck et al., 2009) and Beck-Anxiety-Inventory (BAI, Beck et al., 2007)
• Driving and behaviour avoidance in the simulator during the simulator sessions by means of the S.A.F.E.-ratings of the traffic psychologist and ratings of the therapist by means of a half-standardized observation form
• Simulator Sickness before and after each simulator session by means of a list of symptoms according to Kennedy et al. (1993)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/04/08
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   63   Years
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Additional Inclusion Criteria

• car drivers aged with severe symptoms of fear and avoidance of driving a car (completely or related to specific driving situations)
• since at least four weeks
• triggered by a traffic accident or another critical event in traffic
• valid driving license and regular driving experience prior to the triggering event
• diagnoses: adjustment disorder, specific (isolated) phobia or posttraumatic stress disorder
• no prior exposure therapy in vivo (exceptions: mere exposure to sitting in a car, cancelled exposure)
• no or stable therapy with psychoactive drugs since at least four weeks

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Exclusion Criteria

• alcohol/drug addiction
• triggering event happened under the influence of alcohol/drugs
• suicidality
• psychosis and other premorbid mental disorders and comorbidities such as coronary heart disease and epilepsy as well as severe cognitive impairment and other findings rated to be a contraindication to an exposure therapy during the investigation at the Medical Study Center Würzburg
• for females only: positive pregnancy test.

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Addresses

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    • Deutsche Gesetzliche Unfallversicherung (DGUV)
    • Alte Heerstraße 111
    • 53754  Sankt Augustin
    • Germany
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    • Würzburger Institut für Verkehrswissenschaften (WIVW GmbH)
    • Ms.  Dr.  Ramona  Kenntner-Mabiala 
    • Robert-Bosch-Str. 4
    • 97219  Veitshöchheim
    • Germany
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    • Psychotherapeutische Hochschulambulanz der Universität Würzburg
    • Ms.  Dipl.-Psych.  Anna  Kuraszkiewicz  
    • Marcusstraße 9-11
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesetzliche Unfallversicherung (DGUV
    • 53754  Sankt Augustin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/02
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Trial Publications, Results and other Documents

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