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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027328 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tr1 group | Experimental | 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. |
|
| Tr2 group | Experimental | 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. |
|
| Active control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based intervention for dental anxiety | Behavioral | 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. |
| 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 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) | 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. |
| 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. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. | baseline assessment, and at one- and three-month follow-ups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisol Tellez Merchan, PhD | Professor | Principal Investigator |
| Eugene M Dunne, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maurice H Kornberg School of Dentistry Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7584581 | Background | 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. | |
| 22876395 | Background | 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. |
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Participants were randomly assigned to one of three arms after their baseline visit was completed. Please see more information about individual arms below.
To be eligible, patients had to be between 18 and 75 years of age, fluent in spoken and written English, have scheduled a dental treatment appointment, be willing and able to give informed consent, participate responsibly in the study protocol, meet criteria for high dental anxiety based on the MDAS, and endorse at least some oral-health related impairment at the administration of a semi-structured diagnostic interview. Recruitment was carried out at Temple University School of Dentistry clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychology Intervention | Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows) |
| FG001 | Dental Intervention | Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants). |
| FG002 | Control | These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
499 total participants were analyzed for this study. However, 503 were enrolled. 4 participants failed to randomize and were excluded from all analysis. All demographic and outcome information reports those 499 participants, but n=503 reported elsewhere reflects the total number of participants who were initially enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychology Intervention | Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows) |
| BG001 | Dental Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall number of participants analyzed reflects baseline enrollment numbers. 1 Month and 3 Month MDAS reports a smaller n due to participant dropout throughout the study. | Posted | Mean | Standard Deviation | score on a scale | The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups. |
|
From Baseline to 3-month follow up, around 12 weeks
Adverse events for this study adhere to the definition provided by ClinicalTrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychology Intervention | Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased anxiety post-intervention | Psychiatric disorders | Systematic Assessment | At 1-month, pt reported increased anxiety due to intervention, but was willing to continue with successive follow-ups. Pt continued attending dental apt and completed all measures. Event was assessed as "mild" and reported in MMOR. |
Only dental treatment-seeking patients who initiated contact with the TUKSoD clinics were recruited into the study (potential for sampling bias).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Dean for Research & Chair Department of Oral Health Sciences | Temple University Kornberg School of Dentistry | 215-707-1773 | marisol.tellez.merchan@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2023 | Apr 7, 2025 | Prot_SAP_000.pdf |
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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.
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Given the obvious differences between those who will receive the Internet-based dental anxiety and those who will not (i.e., those who are assigned to the control condition), we will not be able to blind patients to this aspect of randomization. Patients will not be informed about the professional affiliation of therapy aides, who will dress similarly (e.g., professional dress and a lab coat) and who will be instructed not to respond to questions related to this topic.
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|
| 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 post-appointment debriefing interview, 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. The minimum PSI score is 0, while the maximum PSI score is 112. | 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 minimum score of 8 and a maximum score of 32. | The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as 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. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. | 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 |
| 20463579 | Background | 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. |
| 11690728 | Background | 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. |
| 23746494 | Background | 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. |
| 26202996 | Background | 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. |
| 1540116 | Background | 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. |
| Background | 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 |
| 526242 | Background | 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. |
| 10245370 | Background | 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. |
| Background | 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. |
| 40514778 | Derived | Tellez M, Dunne EM, Konneker E, Zhao H, Ismail AI. Online Cognitive-Behavioural Intervention to Manage Dental Anxiety: A 12-Month Randomised Clinical Trial. Community Dent Oral Epidemiol. 2025 Oct;53(5):543-555. doi: 10.1111/cdoe.13049. Epub 2025 Jun 13. |
Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).
| BG002 | Control | These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Modified Dental Anxiety Scale | The MDAS is a 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. | Mean | Standard Deviation | Score on a Scale |
|
Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)
| OG001 | Dental Intervention | Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants). |
| OG002 | Control | These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video. |
|
|
| Primary | 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. | Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.) | Posted | Mean | Standard Deviation | score on a scale | The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups. |
|
|
|
| Secondary | 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. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. | Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.) | Posted | Mean | Standard Deviation | score on a scale | baseline assessment, and at one- and three-month follow-ups. |
|
|
|
| Secondary | 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. | The question, "How much pain do you expect to experience during your next similar dental procedure?" was asked to pts as part of the PI-NRS following their dental appointment, at 1-month, and at 3-months follow up. | Posted | Count of Participants | Participants | These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups. |
|
|
|
| Secondary | 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. The minimum PSI score is 0, while the maximum PSI score is 112. | Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the PSI were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures. | Posted | Mean | Standard Deviation | score on a scale | It will be administered at baseline and the 1-month and 3-month follow-ups. |
|
|
|
| Secondary | 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. | Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the DTS were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures. | Posted | Mean | Standard Deviation | score on a scale | The DTS will be administered at the baseline assessment and at one- and three-month follow-ups |
|
|
|
| Secondary | 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. | Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the FQBII were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures. | Posted | Mean | Standard Deviation | score on a scale | It will be administered at the baseline assessment and at one- and three-month follow-ups. |
|
|
|
| Secondary | 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 minimum score of 8 and a maximum score of 32. | Differences in number of participants analyzed at each time point is due to participant drop-out throughout the study. Additionally, participants in the control condition were not administered the CSQ since the questions were not relevant to the time-and attention-matched nature video they were assigned. | Posted | Mean | Standard Deviation | score on a scale | The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups. |
|
|
|
| Secondary | 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. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. | Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation | Posted | Mean | Standard Deviation | score on a scale | baseline assessment, and at one- and three-month follow-ups. |
|
|
|
| Secondary | 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. | Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.) | Posted | Count of Participants | Participants | baseline assessment, and at one- and three-month follow-ups. |
|
|
|
| Secondary | 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. | Pre-Intervention = the period of 12 months preceding the participant's intervention or control visit Post-Intervention = the period of 12 months following the participant's intervention or control visit | Posted | Mean | Standard Deviation | Number of Appointments | 1 year post-dental anxiety intervention |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | Dental Intervention | Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants). | 0 | 167 | 0 | 167 | 1 | 167 |
| EG002 | Control | These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video. | 0 | 170 | 0 | 170 | 0 | 170 |
|
Not provided
Not provided
| 1 Month |
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| 3 Month |
|
|
| 1 Month |
|
|
| 3 Months |
|
|
| 1 |
|
| 2 - Mild Pain |
|
| 3 |
|
| 4 - Moderate Pain |
|
| 5 |
|
| 6 - Severe Pain |
|
| 7 |
|
| 8 - Very Severe Pain |
|
| 9 |
|
| 10 - Worst Possible Pain |
|
| 1-Month Follow Up |
|
|
| 3-Month Follow Up |
|
|
| 1 Month |
|
|
| 3 Months |
|
|
| 1 Month |
|
|
| 3 Months |
|
|
| 1 Month |
|
|
| 3 Months |
|
|
| 1-Month |
|
|
| 3-Months |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
| 1 Month |
|
|
| 3 Month |
|
|
|
| Pre-Completion Rate (Pre-Intervention) |
|
| Appointments Cancelled (Pre-Intervention) |
|
| Appointments No Showed (Post-Intervention) |
|
| Appointments Completed (Post-Intervention) |
|
| Post-Completion Rate (Post-Intervention) |
|
| Appointments Cancelled (Post-Intervention) |
|