Efficacy of an Internet-based Intervention for Dental Anxiety

Dental Anxiety Clinical Trial

Official title: Efficacy of an Internet-based Intervention for Dental Anxiety

Status Active, not recruiting

Clinical Trial Summary

The overall objective of the activities described in this protocol is to examine the efficacy of the Internet-based intervention in the reduction of dental anxiety in patients seeking dental treatment. This study has 2 primary objectives and 2 secondary objectives:

Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention.

Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition.

Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition.

Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.

Clinical Trial Description

This clinical trial 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 the clinics of a university dental school. The primary objective of human subjects activities described in this protocol is to evaluate the efficacy of the Internet-based intervention for dental anxiety among patients presenting to the participating clinic(s). To achieve this overall objective, 2 primary objectives and 2 secondary objectives have been proposed:

Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.

Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.

Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition.

Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.

Patients (N=450) between the ages of 18 and 75 attending the Temple University Kornberg School of Dentistry (TUKSoD) dental clinics and reporting high dental anxiety that causes at least mild impairment will be recruited and consented. To obtain the sample, the investigators will screen all patients who present to the Faculty Practice Clinic (FPC) of TUKSoD (as well as the Graduate Clinics of TUKSoD [Endodontology, Periodontology, Advanced Education General Dentistry], if necessary). Total participation time for each patient is approximately 4 months but could be slightly longer pending the interval between screening/baseline and the scheduled date of the dental anxiety intervention/dental appointment. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

• NCT number: NCT03680755
• Study type: Interventional
• Source: Temple University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 24, 2019
• Completion date: September 10, 2024