This is an application submitted under PAR-15-059 ?NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01).? The clinical trial proposed herein will evaluate the efficacy of a brief Internet- based cognitive-behavioral intervention for the treatment of impairing dental anxiety among those seeking dental care at a university clinic. Preliminary experience with pilot subjects as well as the results of a randomized controlled trial with a computer-based version of this intervention, delivered in the 60 minutes before a scheduled dental appointment, have shown it to be acceptable to patients and provided initial evidence for its efficacy. However, the intervention has only been formally evaluated when administered with the assistance of clinical psychology personnel trained in the cognitive-behavioral treatment of anxiety disorders, which represents a potentially significant limitation to its implementation in dental settings where highly trained psychological personnel are a scarce resource. The planned U01 clinical trial will evaluate the efficacy of the Internet-based version of this intervention assisted by clinical psychology personnel and compare it to the efficacy of the intervention when assisted by dental staff. A finding that the intervention is efficacious, and equivalently so when assisted by dental personnel as when assisted by clinical psychology personnel, will make the dissemination and implementation of the intervention in a sustainable fashion much more feasible. This U01 application will build on a previous Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34), in which the feasibility and acceptability of the Internet-based version of the intervention were examined, materials for the training of dental staff were developed, a number of dental staff were trained to criterion, measures of intervention knowledge and fidelity of administration were developed and piloted, and dental staff (as well as psychology staff) administered the intervention to a small set of patients. Now we seek to fully evaluate whether the intervention administered by dental staff compares well to the intervention when administered by cognitive behaviorally trained clinical psychology personnel. In these two arms of the study, the treating dental provider will also be informed of the patient's score on a measure of dental anxiety, and a third arm of the study, in which informing the treating dental provider of the patient's score on a dental anxiety scale will be the sole intervention, will serve as a control condition. Primary (self-rated and assessor-rated dental anxiety/fear) and secondary outcome measures (e.g., pain sensitivity, distress tolerance, client satisfaction, blood-injury-injection phobia) will be administered at baseline and 1 and 3 months following the day of administration of the dental anxiety intervention. Attendance at scheduled dental appointments over the following 12-month period will also be examined to determine whether the intervention affects avoidance of dental procedures. Further analyses will examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the Internet-based intervention in reducing dental anxiety across providers.
The proposed clinical trial will evaluate the efficacy of a brief Internet-based cognitive-behavioral intervention for the treatment of impairing dental anxiety when administered with the assistance of either clinical psychology personnel trained in the cognitive-behavioral treatment of anxiety disorders or by dental staff who have received only intervention-specific training. A finding that the intervention is equivalently efficacious when assisted by dental staff will make the dissemination and implementation of the intervention in a sustainable fashion much more feasible.
