This is an application for an NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34). It is intended to support activities in preparation for a later Clinical Trial Application (U01). The subsequent clinical trial will evaluae 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 studies with a computer-based version of this intervention, delivered in the hour before a scheduled dental appointment, have shown it to be acceptable to patients and provided modest evidence for its efficacy. To date, the intervention has been administered only with the assistance of clinical psychology personnel trained in the cognitive- behavioral treatment of anxiety disorders, but this represents a potentially significant limitation to its implementation i 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 a control condition in which the treating dentist is simply informed of the patient's score on a dental anxiety scale. More importantly, it will also evaluate the efficacy of the intervention when assisted by dental hygienists. 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. Activities planned under the R34 award include completion of several administrative tasks including preparation of materials for human subjects review, that will allow for rigorous conduct of the subsequent clinical trial, as well as a number of other tasks including (1) the evaluation of the feasibility and acceptability to patients of the internet-based version of the intervention, (2) the development of training materials for dental hygienists, who may have had little exposure to cognitive-behavioral interventions and assessment devices to measure the knowledge gained as a result of this training, (3) having hygienists who have completed this training apply the intervention to a sample of patients seeking dental care, and making modification to training and assessment procedures on the basis of these experiences, (4) development of measures of treatment fidelity for use in the U01 trial, and (5) preparation of the formal U01 application.
This is an application for a planning grant to support activities in preparation for a later clinical trial. The clinical trial will evaluate the efficacy of a briefinternet-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 hygienists who have received only intervention-specific training. A finding that the intervention is equivalently efficacious when assisted by dental hygienists will make the dissemination and implementation of the intervention in a sustainable fashion much more feasible. Several activities planned under this award will prepare the research team to best administer this clinical trial.
