- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207960
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia (EMDR-DP)
A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Muenster, Germany, 48149
- Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EMDR
Eye Movement Desensitization and Reprocessing
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The intervention consists of three 90-minute sessions of individual psychotherapy.
Sessions take place weekly according to a treatment manual.
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No Intervention: WLC
Wait-list control group.
EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental anxiety
Time Frame: 4 weeks
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Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
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4 weeks
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Dental anxiety
Time Frame: 3 months
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Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
|
3 months
|
Dental anxiety
Time Frame: 12 months
|
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General psychopathology
Time Frame: 4 weeks, 3 months, 12 months
|
General psychopathology is assessed by the Brief Symptom Scale (BSI).
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4 weeks, 3 months, 12 months
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Anxiety and depression
Time Frame: 4 weeks, 3 months, 12 months
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Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).
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4 weeks, 3 months, 12 months
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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.
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4 weeks
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Dental treatment
Time Frame: 3 months, 12 months
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Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?
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3 months, 12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- De Jongh A, van den Oord HJ, ten Broeke E. Efficacy of eye movement desensitization and reprocessing in the treatment of specific phobias: Four single-case studies on dental phobia. J Clin Psychol. 2002 Dec;58(12):1489-503. doi: 10.1002/jclp.10100.
- de Jongh A, Fransen J, Oosterink-Wubbe F, Aartman I. Psychological trauma exposure and trauma symptoms among individuals with high and low levels of dental anxiety. Eur J Oral Sci. 2006 Aug;114(4):286-92. doi: 10.1111/j.1600-0722.2006.00384.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-137-f-S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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