The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia

Dental Phobia Clinical Trial

— VR-DENT  

Official title:

The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03098134
• Other study ID #: VR-DENT-1
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 14, 2017
• Last updated: March 27, 2017
• Start date: April 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: March 2017
• Source: Ruhr University of Bochum
• Contact: Dirk Adolph, Dr.
• Phone: +492343223177
• Email: dirk.adolph[@]rub.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed Specific Dental Phobia

Exclusion Criteria:

• Schizophrenia or other Psychotic Illnesses

• Bipolar Disorder

• Chronic Headache

• other neurological disorders such as epilepsy

• Hearing problems

Related Conditions & MeSH terms

• Dental Phobia
• Phobic Disorders

Intervention

Behavioral:
• Behavior Therapy
Virtual Reality and Video based Exposure Therapy

Other:
• Health Education
Video based health education covering common myths and false believes about dental surgeries

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Ruhr University of Bochum (Dr. Andre Wannemüller), Ruhr University of Bochum (Prof. Dr. Jürgen Margraf), Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in dental avoidance behavior	Each participant will be asked to arrange an appointment in a cooperating dental Hospital. It will be assessed (1) if participant makes a - (2) and attends to - first appointment (3) if participant tolerates oral inspection and dental treatment (4) how many further appointments will be made	within three month after the therapy took place
Primary	Change in Subjective Dental Anxiety	Assessed at time 0 (at inclusion) 1 (pre therapy, two weeks after inclusion), 2(post therapy, 2 weeks after time 1) and at follow up (4 month after time 0) with Dental Anxiety Scale (DAS, 4-item scale, range 4-20)	4 month
Primary	Change in Dysfunctional Dental Cognitions	Assessed with Dental Cognition Questionnaire (DCQ, 38 dichotomous items, range 0-38) Assessed at time 0 (at inclusion), time 1 (pre therapy, two weeks after time 0), time 2 (post therapy, 2 weeks after time 1) and at follow up (4 month after time 0)	4 months
Secondary	Change in Psychophysiological defensive reactivity	Participants will take part in a passive Picture viewing paradigm. They will be exposed to dental anxiety related Pictures, generally negative pictures, neutral, and positive pictures. Outcome measures will be withdrawal-related motor responding (assessed with the startle-reflex), as well as heart frequency change towards the pictures, The task will be applied at inclusion (time 0) and post therapy (4 weeks after inclusion)	4 weeks