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

Primary Purpose

Dental Phobia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing (EMDR)
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Phobia focused on measuring dental phobia, psychotherapy, eye movement desensitization and reprocessing - EMDR, efficacy, wait-list control

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

EMDR

WLC

Arm Description

Eye Movement Desensitization and Reprocessing

Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval.

Outcomes

Primary Outcome Measures

Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).

Secondary Outcome Measures

General psychopathology
General psychopathology is assessed by the Brief Symptom Scale (BSI).
Anxiety and depression
Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).
Behavioral test
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.
Dental treatment
Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?

Full Information

First Posted
June 29, 2010
Last Updated
May 3, 2012
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT01207960
Brief Title
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia
Acronym
EMDR-DP
Official Title
A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Phobia
Keywords
dental phobia, psychotherapy, eye movement desensitization and reprocessing - EMDR, efficacy, wait-list control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMDR
Arm Type
Active Comparator
Arm Description
Eye Movement Desensitization and Reprocessing
Arm Title
WLC
Arm Type
No Intervention
Arm Description
Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Description
The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.
Primary Outcome Measure Information:
Title
Dental anxiety
Description
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Time Frame
4 weeks
Title
Dental anxiety
Description
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Time Frame
3 months
Title
Dental anxiety
Description
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
General psychopathology
Description
General psychopathology is assessed by the Brief Symptom Scale (BSI).
Time Frame
4 weeks, 3 months, 12 months
Title
Anxiety and depression
Description
Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).
Time Frame
4 weeks, 3 months, 12 months
Title
Behavioral test
Description
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.
Time Frame
4 weeks
Title
Dental treatment
Description
Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?
Time Frame
3 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Doering, MD
Organizational Affiliation
University of Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12455017
Citation
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.
Results Reference
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PubMed Identifier
16911099
Citation
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.
Results Reference
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Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia

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