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

NCT03098134 | Unknown Phase 2

• 1 other identifier: VR-DENT-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dental Phobia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Psychophysiological defensive reactivity

  4 weeks

Other Outcomes (1)

• Change in dental avoidance behavior

  within three month after the therapy took place

Study Arms (2)

VR-Video-Exposure

EXPERIMENTAL

Behavioral: Behavior Therapy

Education-Video-

ACTIVE COMPARATOR

Other: Health Education

Interventions

Behavior Therapy BEHAVIORAL

Virtual Reality and Video based Exposure Therapy

VR-Video-Exposure

Health Education OTHER

Video based health education covering common myths and false believes about dental surgeries

Education-Video-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- diagnosed Specific Dental Phobia

You may not qualify if:

• Schizophrenia or other Psychotic Illnesses
• Bipolar Disorder
• Chronic Headache
• other neurological disorders such as epilepsy
• Hearing problems

Sponsors & Collaborators

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

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Dirk Adolph, Dr.

CONTACT

+492343223177; dirk.adolph@rub.de

Andre Wannemueller, Dr.

CONTACT

+492343223106; andre.wannemueller@rub.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Psychophysiology Lab

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 31, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: May 1, 2018
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share