Clinical trial NCT03680755: Efficacy of an Internet-based Intervention for Dental Anxiety
Official title: Efficacy of an Internet-based Intervention for Dental Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Anxiety
Keywords: dental avoidance
dental phobia
pain sensitivity
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2018-09-21
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a single-center parallel groups study with randomization to one of three arms: (1) a treatment condition (Tr1) in which the dental anxiety intervention is administered by CBT personnel (n=150), (2) a treatment condition in which the dental anxiety intervention is administered by dental staff (Tr2) (n=150), or (3) an active control (AC) group (notification of the dental providers of the patient's score on a dental anxiety scale before their dental treatment appointment). In addition, control participants will be asked to view a video of nature scenes for a period of time equivalent to the dental anxiety intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
timeFrame: The MDAS will be administered at initial screening, baseline assessment, and at one- and three-month follow-ups.
measure: 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.
Secondary outcomes:
measure: Change in Avoidance Rating from the ADIS-5
timeFrame: baseline assessment, and at one- and three-month follow-ups.
measure: Pain Intensity Numeric Rating Scale (PI-NRS).
timeFrame: These ratings will be administered as part of the interviews on the day of the dental anxiety intervention as well as at the 1-month and 3-month follow-ups.
measure: Pain Sensitivity Index (PSI; Gross, 1992a).
timeFrame: It will be administered at baseline and the 1-month and 3-month follow-ups.
measure: Distress Tolerance Scale (DTS; Simons & Gaher, 2005).
timeFrame: The DTS will be administered at the baseline assessment and at one- and three-month follow-ups
measure: Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).
timeFrame: It will be administered at the baseline assessment and at one- and three-month follow-ups.
measure: Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).
timeFrame: The CSQ-8 will be administered at the one- and three-month follow-ups.
measure: Change in Distress and Interference Rating from the ADIS-5
timeFrame: baseline assessment, and at one- and three-month follow-ups.
measure: Change in percentage of dentally phobic patients from the ADIS-5
timeFrame: baseline assessment, and at one- and three-month follow-ups.
measure: Change in Attendance at Dental Appointments
timeFrame: 1 year post-dental anxiety intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Maurice H Kornberg School of Dentistry Temple University
state: Pennsylvania
Study officials:
affiliation: Professor
name: Marisol Tellez Merchan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Eugene M Dunne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
citation: Brahm CO, Lundgren J, Carlsson SG, Nilsson P, Corbeil J, Hagglin C. Dentists' views on fearful patients. Problems and promises. Swed Dent J. 2012;36(2):79-89.
citation: Farrar JT, Polomano RC, Berlin JA, Strom BL. A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity. Anesthesiology. 2010 Jun;112(6):1464-72. doi: 10.1097/ALN.0b013e3181de0e6d.
citation: Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
citation: Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
citation: Tellez M, Potter CM, Kinner DG, Jensen D, Waldron E, Heimberg RG, Myers Virtue S, Zhao H, Ismail AI. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):174S-80S. doi: 10.1177/0022034515598134. Epub 2015 Jul 22.
citation: Gross PR. Is pain sensitivity associated with dental avoidance? Behav Res Ther. 1992 Jan;30(1):7-13. doi: 10.1016/0005-7967(92)90090-4.
citation: Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and Emotion, 29(2), 83-102. http://dx.doi.org/10.1007/s11031-005-7955-3
citation: Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
citation: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
citation: Potter CM, Jensen D, Kinner D, Tellez M, Ismail AI, Heimberg RG. Single-session computerized cognitive behavioral therapy for dental anxiety: A case series. Clinical Case Studies. 2016;15(1):3-17.