Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01207960
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2010-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057169', 'term': 'Eye Movement Desensitization Reprocessing'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2010-06-29', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental anxiety', 'timeFrame': '4 weeks', 'description': 'Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).'}, {'measure': 'Dental anxiety', 'timeFrame': '3 months', 'description': 'Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).'}, {'measure': 'Dental anxiety', 'timeFrame': '12 months', 'description': 'Dental anxiety is assessed by the Dental Anxiety Scale (DAS) and the Dental Fear Survey (DFS).'}], 'secondaryOutcomes': [{'measure': 'General psychopathology', 'timeFrame': '4 weeks, 3 months, 12 months', 'description': 'General psychopathology is assessed by the Brief Symptom Scale (BSI).'}, {'measure': 'Anxiety and depression', 'timeFrame': '4 weeks, 3 months, 12 months', 'description': 'Anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS).'}, {'measure': 'Behavioral test', 'timeFrame': '4 weeks', '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.'}, {'measure': 'Dental treatment', 'timeFrame': '3 months, 12 months', 'description': 'Does the patient tolerate dental treatment within 3 and 12 months after Eye Movement Desensitization and Reprocessing (EMDR)?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental phobia', 'psychotherapy', 'eye movement desensitization and reprocessing - EMDR', 'efficacy', 'wait-list control'], 'conditions': ['Dental Phobia']}, 'referencesModule': {'references': [{'pmid': '12455017', 'type': 'BACKGROUND', '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.'}, {'pmid': '16911099', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEye 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.\n\nRecently 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.\n\nA 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.\n\nThis randomized wait-list control study aims to evaluate the efficacy of EMDR in a larger sample of dental phobia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dental phobia according to the World Health Organization´s International Classification of Diseases, ICD-10 (F40.2)\n\nExclusion Criteria:\n\n* schizophrenic disorder\n* severe depression\n* severe dissociative disorder\n* organic brain disease\n* anorexia nervosa (body mass index, BMI \\< 17)\n* suicidality\n* severe cardio-vascular disease\n* ophthalmic disease\n* pregnancy and lactation\n* psychopharmacological treatment\n* substance abuse'}, 'identificationModule': {'nctId': 'NCT01207960', 'acronym': 'EMDR-DP', 'briefTitle': 'Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Dental Phobia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'A Randomized Wait-list Control Study of the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) in Patients With Dental Phobia', 'orgStudyIdInfo': {'id': '2007-137-f-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EMDR', 'description': 'Eye Movement Desensitization and Reprocessing', 'interventionNames': ['Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)']}, {'type': 'NO_INTERVENTION', 'label': 'WLC', 'description': 'Wait-list control group. EMDR treatment takes place after 4 weeks of no treatment which represents the wait-list comparison interval.'}], 'interventions': [{'name': 'Eye Movement Desensitization and Reprocessing (EMDR)', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.', 'armGroupLabels': ['EMDR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Psychosomatics in Dentistry, Dept. of Prosthodontics & Material Science, University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Stephan Doering, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Muenster, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr.', 'investigatorFullName': 'doerings', 'investigatorAffiliation': 'University Hospital Muenster'}}}}