CompletedNot Applicable

Efficacy of an Internet-based Intervention for Dental Anxiety

United States503 participantsStarted 2019-07-24

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).

Timeframe: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.

Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014)

Timeframe: The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups.

Trial details

NCT IDNCT03680755

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-03

Results submitted2025-04-22

View on ClinicalTrials.gov More Dental Anxiety trials