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Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia (EMDR-DP)

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ClinicalTrials.gov Identifier: NCT01207960
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to find out whether Eye Movement Desensitization and Reprocessing (EMDR) is effective in the treatment of patients with dental phobia.

Condition or disease Intervention/treatment
Dental Phobia Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Detailed Description:

Dental phobia represents a clinical condition that affects 5-15% of the community and is characterized by severe anxiety of dental treatment which leads to avoidance of treatment and, as a consequence, severe dental as well as psychosocial problems.

Eye Movement Desensitization and Reprocessing (EMDR) has been developed for the treatment of patients with post traumatic stress disorder (PTSD). Its efficacy in PTSD patients has often been demonstrated in randomized controlled trials.

Recently it has been demonstrated that dental phobia is often induced by traumatic events during dental treatment and goes along with symptoms of PTSD in numerous patients.

A pilot study (de Jongh et al. 2002) gave hints on the efficacy of EMDR in four dental phobia patients with a history of traumatization during dental treatment.

This randomized wait-list control study aims to evaluate the efficacy of EMDR in a larger sample of dental phobia patients.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia
Study Start Date : January 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: EMDR
Eye Movement Desensitization and Reprocessing
Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.
No Intervention: WLC
Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval.


Outcome Measures

Primary Outcome Measures :
  1. Dental anxiety [ Time Frame: 4 weeks ]
    Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).

  2. Dental anxiety [ Time Frame: 3 months ]
    Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).

  3. Dental anxiety [ Time Frame: 12 months ]
    Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).


Secondary Outcome Measures :
  1. General psychopathology [ Time Frame: 4 weeks, 3 months, 12 months ]
    General psychopathology is assessed by the Brief Symptom Scale (BSI).

  2. Anxiety and depression [ Time Frame: 4 weeks, 3 months, 12 months ]
    Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).

  3. Behavioral test [ Time Frame: 4 weeks ]
    Dentral anxiety is assessed during a dental visit before and after treatment/wait-list control condition by means of a standardized behavior obeservation and interview.

  4. Dental treatment [ Time Frame: 3 months, 12 months ]
    Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dental phobia according to the World Health Organization´s International Classification of Diseases, ICD-10 (F40.2)

Exclusion Criteria:

  • schizophrenic disorder
  • severe depression
  • severe dissociative disorder
  • organic brain disease
  • anorexia nervosa (body mass index, BMI < 17)
  • suicidality
  • severe cardio-vascular disease
  • ophthalmic disease
  • pregnancy and lactation
  • psychopharmacological treatment
  • substance abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207960


Locations
Germany
Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Stephan Doering, MD University of Muenster, Germany
More Information

Publications:
Responsible Party: doerings, Univ.-Prof. Dr., University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01207960     History of Changes
Other Study ID Numbers: 2007-137-f-S
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by doerings, University Hospital Muenster:
dental phobia
psychotherapy
eye movement desensitization and reprocessing - EMDR
efficacy
wait-list control

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders