The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia (VR-DENT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Phobia
• Intervention / Treatment: Behavioral: Behavior Therapy; Other: Health Education

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-Video-Exposure	Behavioral: Behavior Therapy; Virtual Reality and Video based Exposure Therapy
Active Comparator: Education-Video-	Other: Health Education; Video based health education covering common myths and false believes about dental surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: Ruhr University of Bochum (Dr. Andre Wannemüller); Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren); Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: VR-DENT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No