Efficacy of an Internet-based Intervention for Dental Anxiety

Temple University

Status: Completed

Conditions: Dental Anxiety

Treatments: Behavioral: Internet-based intervention for dental anxiety

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03680755

U01DE027328 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 503 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient endorses 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
• be between 18 and 75 years of age
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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503 participants in 3 patient groups

Tr1 group

Experimental group

Description:

Participants assigned to Tr1 will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.

Treatment:

Behavioral: Internet-based intervention for dental anxiety

Tr2 group

Experimental group

Description:

Participants assigned to Tr2 will complete the experimental dental anxiety management program, which will be facilitated by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.

Treatment:

Behavioral: Internet-based intervention for dental anxiety

Active control

No Intervention group

Description:

Participants assigned to the control group, will not complete the experimental dental anxiety management program at this time. They will complete study paperwork and watch a non-dental video for 45 minutes before their scheduled dental appointment. Immediately after the dental appointment, they will complete a brief interview with the research staff person.