Efficacy of an Internet-based Intervention for Dental Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of an Internet-based Intervention for Dental Anxiety

Conditions
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Dental Anxiety

Intervention / Treatment
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* Behavioral: Internet-based intervention for dental anxiety


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tr1 group<br>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. | Behavioral: Internet-based intervention for dental anxiety<br>* Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or 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.<br>|
| Experimental: Tr2 group<br>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. | Behavioral: Internet-based intervention for dental anxiety<br>* Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or 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.<br>|
| No Intervention: Active control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, If you were about to have your tooth drilled, how would you feel? Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies. | The MDAS will be administered at initial screening, 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) | The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5. | The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Avoidance Rating from the ADIS-5 | The rating of avoidance included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. | baseline assessment, and at one- and three-month follow-ups. | 
| Pain Intensity Numeric Rating Scale (PI-NRS). | The PI-NRS is a widely utilized 11-point self-report measure that assesses physical pain intensity on a scale ranging from 0 (no pain) to 10 (worst possible pain). Anxiety increases subjective pain experience, and therefore this scale will be used to assess the intensity of dental-related pain that participants expect to experience at their dental appointment scheduled after the dental anxiety intervention (or control), the intensity of pain they actually experienced, and the intensity of pain they expect to experience at their next similar dental appointment. | 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. | 
| Pain Sensitivity Index (PSI; Gross, 1992a). | The PSI is a 16-item self-report measure that assesses the fearful appraisal of pain and the expected physical, psychological, and social consequences of pain. Items are rated on a scale ranging from 0 (not at all) to 7 (very much) reflecting the degree to which the item applies to the respondent. Higher scores indicate higher levels of pain sensitivity. | It will be administered at baseline and the 1-month and 3-month follow-ups. | 
| Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | The DTS is a 15-item self-report measure assessing one's perceived ability to experience and tolerate negative emotional states. This scale measures four dimensions of distress tolerance: subjective appraisal of distress, ability to tolerate emotional distress, absorption of attention by negative emotions, and regulation efforts to alleviate distress. Items are rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total score range from 15 to 75, with higher scores reflecting higher levels of distress tolerance. | The DTS will be administered at the baseline assessment and at one- and three-month follow-ups | 
| Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | The FQ-BII is a 5-item subscale of the complete FQ. It assesses the degree to which an individual avoids situations involving blood-injury-injection because of fear, including in the context of dental procedures. Items are rated on a scale ranging from 0 (would not avoid it) to 8 (would always avoid it). Total scores range from 0-40 with higher scores indicating greater phobic avoidance. | It will be administered at the baseline assessment and at one- and three-month follow-ups. | 
| Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | The CSQ-8 is used in the measurement of client/patient assessment of satisfaction with services and clinical care. It consists of 8 items rated on a 1-to-4 scale. Higher scores indicate greater satisfaction with services, with a maximum score of 32. | The CSQ-8 will be administered at the one- and three-month follow-ups. | 
| Change in Distress and Interference Rating from the ADIS-5 | The rating of distress and interference included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. | baseline assessment, and at one- and three-month follow-ups. | 
| Change in percentage of dentally phobic patients from the ADIS-5 | Percentage of patients who meet criteria for a specific phobia of dental procedures at baseline. We will examine whether this percentage decreases as a function of the arm of the study to which patients are assigned. | baseline assessment, and at one- and three-month follow-ups. | 
| Change in Attendance at Dental Appointments | We will utilize TUKSoD's automated scheduling system (axiUm, http://www.axiumdental.com/) to collect information about dental attendance. | 1 year post-dental anxiety intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental avoidance, dental phobia, pain sensitivity