Dental PhobiaEMDR-DPNCT01207960
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Dental Phobia, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Phobia
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Sep 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dental phobia according to the World Health Organization´s International Classification of Diseases, ICD-10 (F40.2)
Who cannot join
- schizophrenic disorder
- severe depression
- severe dissociative disorder
- organic brain disease
- anorexia nervosa (body mass index, BMI < 17)
- suicidality
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- severe cardio-vascular disease
- ophthalmic disease
- pregnancy and lactation
- psychopharmacological treatment
- substance abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster
Münster, 48149
About this study
Official title: A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia
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.
Read the 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.
- Conditions
- Dental Phobia
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR)
- Keywords
- dental phobia, psychotherapy, eye movement desensitization and reprocessing - EMDR, efficacy, wait-list control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR)Behavioural
The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.
| Study group | Role | What they receive |
|---|---|---|
| EMDR | Active comparator | Eye Movement Desensitization and Reprocessing Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) |
| WLC | No intervention | Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Measured: 4 weeks
Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Measured: 3 months
Dental anxiety
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Measured: 12 months
Secondary outcomes (4)
General psychopathology
General psychopathology is assessed by the Brief Symptom Scale (BSI).
Measured: 4 weeks, 3 months, 12 months
Anxiety and depression
Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).
Measured: 4 weeks, 3 months, 12 months
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.
Measured: 4 weeks
Dental treatment
Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doerings, University Hospital Muenster
- Investigators
- Stephan Doering, MD, Principal investigator, University of Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207960
- Sponsor's protocol ID
- 2007-137-f-S
- Acronym
- EMDR-DP
- Status last verified
- May 2012
- First submitted
- 29 Jun 2010
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12455017de 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.
PubMed 16911099
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia
- ClinicalTrials.gov ID
- NCT01207960
- Acronym / sponsor ID
- EMDR-DP / 2007-137-f-S
- Conditions
- Dental Phobia
- Keywords
- dental phobia, psychotherapy, eye movement desensitization and reprocessing - EMDR, efficacy, wait-list control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Sep 2010 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR | Active comparator | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)Eye Movement Desensitization and Reprocessing |
| WLC | No intervention | –Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dental phobia according to the World Health Organization´s International Classification of Diseases, ICD-10 (F40.2)
Key exclusion criteria (11 listed)
- schizophrenic disorder
- severe depression
- severe dissociative disorder
- organic brain disease
- anorexia nervosa (body mass index, BMI < 17)
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 (EMDR)The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual. | Behavioural | EMDR |
Primary outcome
Dental anxiety
Time frame: 4 weeks
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Dental anxiety
Time frame: 3 months
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
Dental anxiety
Time frame: 12 months
Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).
4 secondary outcomes
General psychopathology
Time frame: 4 weeks, 3 months, 12 months
Anxiety and depression
Time frame: 4 weeks, 3 months, 12 months
Behavioral test
Time frame: 4 weeks
Dental treatment
Time frame: 3 months, 12 months
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 4 May 2012.
- Background: PubMed 12455017De 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.
- Background: PubMed 16911099de 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.
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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.
Stephan Doering, MD principal investigator
University of Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Dental Phobia, run by University Hospital Muenster at 1 site in Germany.
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 11 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 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dental anxiety (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207960, which also lists 2 linked publications.
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 4 May 2012.