Overview

This study is examining the efficacy of an Internet-based cognitive-behavioral intervention in helping to reduce anxiety in patients seeking dental treatment. It will be exploring the effectiveness of the intervention by  a) comparing it to a control group and b) exploring how the way it is administered and how the training given to personnel affects the results. The study is also examining whether baseline levels of distress and pain sensitivity affect the success of the intervention, and longer term impacts such as attendance at recall dental visits.

Study Information

This clinical trial will involve an estimated 450 participants. The participants will be randomly divided into one of three different study groups. The study began on July 24th 2019 and is estimated to be completed by July 21st 2023.

Inclusion Criteria

• Patient must have a high dental anxiety (a score of 19 or a score of 4-5 on at least 2 of the 5 items) on the MDAS
• Endorses at least mild impairment as a result of that anxiety at the baseline interview as indexed by the appropriate rating in the specific phobia module of the ADIS-5
• Between 18 and 75 years of age
• Must be sufficiently fluent in written and spoken English in the judgment of project staff that the patient would be able to benefit from the intervention and validly complete the assessments.

Exclusion Criteria

• A self-reported current medical condition (e.g., cardiopulmonary disease, seizure disorder) that might make exposure to anxiety-evoking stimuli inadvisable
• Current suicidal/homicidal ideation/intent or other condition that would take priority over an intervention focused on dental anxiety
• Current psychosis, mental retardation, or other condition that would significantly diminish the patient’s ability to adequately focus attention adaptively on the current protocol
• Inability to give informed consent.

Location

This clinical trial is taking place at Maurice H Kornberg School of Dentistry Temple University, Philadelphia, Pennsylvania, United States, 19140. For further information please contact Richard Heimberg, Ph.D on 215-204-7489 or at heimberg@temple.edu. You may also contact Marisol Tellez Merchan, Ph.D on 215-707-1773 or at marisol@temple.edu.

Sponsors/Collaborators

This study is sponsored by Temple University and National Institute of Dental and Craniofacial Research (NIDCR). Richard G Heimberg, PhD and Marisol Tellez Merchan, PhD are the Principal Investigators.