Trial Outcomes & Findings for Efficacy of an Internet-based Intervention for Dental Anxiety (NCT NCT03680755)

Last Updated: 2025-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

503 participants

Primary outcome timeframe

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

Results posted on

2025-08-17

Participant Flow

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

Participants were randomly assigned to one of three arms after their baseline visit was completed. Please see more information about individual arms below.

Participant milestones

Participant milestones
Measure	Psychology Intervention Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Overall Study STARTED	162	167	170
Overall Study Intervention/Visit Day	121	122	138
Overall Study Post Appointment Debriefing	121	120	135
Overall Study 1-month Follow-up	111	112	123
Overall Study 3-month Follow-up	105	107	118
Overall Study COMPLETED	105	107	118
Overall Study NOT COMPLETED	57	60	52

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of an Internet-based Intervention for Dental Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.	Total n=499 Participants Total of all reporting groups
Age, Continuous	49.7 Years STANDARD_DEVIATION 15.5 • n=5 Participants	49.3 Years STANDARD_DEVIATION 14.3 • n=7 Participants	48 Years STANDARD_DEVIATION 14.8 • n=5 Participants	49 Years STANDARD_DEVIATION 14.9 • n=4 Participants
Sex/Gender, Customized Female	115 Participants n=5 Participants	109 Participants n=7 Participants	125 Participants n=5 Participants	349 Participants n=4 Participants
Sex/Gender, Customized Male	43 Participants n=5 Participants	53 Participants n=7 Participants	44 Participants n=5 Participants	140 Participants n=4 Participants
Sex/Gender, Customized Others	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex/Gender, Customized Unknown/Missing	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	135 Participants n=5 Participants	150 Participants n=7 Participants	149 Participants n=5 Participants	434 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	92 Participants n=5 Participants	99 Participants n=7 Participants	110 Participants n=5 Participants	301 Participants n=4 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	43 Participants n=7 Participants	39 Participants n=5 Participants	129 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	162 Participants n=5 Participants	167 Participants n=7 Participants	170 Participants n=5 Participants	499 Participants n=4 Participants
Modified Dental Anxiety Scale	19.4 Score on a Scale STANDARD_DEVIATION 3.8 • n=5 Participants	19.4 Score on a Scale STANDARD_DEVIATION 3.9 • n=7 Participants	19.8 Score on a Scale STANDARD_DEVIATION 3.1 • n=5 Participants	19.5 Score on a Scale STANDARD_DEVIATION 3.6 • n=4 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). Baseline	19.8 score on a scale Standard Deviation 3.1	19.4 score on a scale Standard Deviation 3.9	19.4 score on a scale Standard Deviation 3.8
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). 1 Month	16.7 score on a scale Standard Deviation 4.7	17.2 score on a scale Standard Deviation 4.6	18 score on a scale Standard Deviation 4.4
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). 3 Month	15.5 score on a scale Standard Deviation 4.9	16.1 score on a scale Standard Deviation 4.8	17 score on a scale Standard Deviation 4.6

PRIMARY outcome

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

Population: 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.)

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=154 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=156 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=167 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
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) Baseline	5.2 score on a scale Standard Deviation 2.0	5.4 score on a scale Standard Deviation 2.2	5.4 score on a scale Standard Deviation 2.0
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) 1 Month	4.8 score on a scale Standard Deviation 2.1	4.7 score on a scale Standard Deviation 2.2	4.8 score on a scale Standard Deviation 2.3
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) 3 Month	4.6 score on a scale Standard Deviation 1.9	4.4 score on a scale Standard Deviation 2.3	4.5 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: baseline assessment, and at one- and three-month follow-ups.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=154 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=156 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=167 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Change in Avoidance Rating From the ADIS-5 Baseline	4.7 score on a scale Standard Deviation 2.3	4.7 score on a scale Standard Deviation 2.4	4.7 score on a scale Standard Deviation 2.4
Change in Avoidance Rating From the ADIS-5 1 Month	3.9 score on a scale Standard Deviation 2.3	3.9 score on a scale Standard Deviation 2.5	3.8 score on a scale Standard Deviation 2.5
Change in Avoidance Rating From the ADIS-5 3 Months	3.7 score on a scale Standard Deviation 2.5	3.7 score on a scale Standard Deviation 2.5	3.5 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 0 - No pain	21 Participants	16 Participants	12 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 1	8 Participants	10 Participants	4 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 2 - Mild Pain	9 Participants	16 Participants	19 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 3	11 Participants	9 Participants	12 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 4 - Moderate Pain	14 Participants	12 Participants	14 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 5	13 Participants	13 Participants	18 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 6 - Severe Pain	11 Participants	9 Participants	8 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 7	2 Participants	3 Participants	9 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 8 - Very Severe Pain	1 Participants	8 Participants	11 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 9	4 Participants	2 Participants	3 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). Post-Appointment · 10 - Worst Possible Pain	10 Participants	9 Participants	16 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 0 - No pain	9 Participants	12 Participants	11 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 1	11 Participants	12 Participants	11 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 2 - Mild Pain	33 Participants	23 Participants	21 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 3	7 Participants	4 Participants	10 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 4 - Moderate Pain	23 Participants	27 Participants	24 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 5	9 Participants	9 Participants	12 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 6 - Severe Pain	9 Participants	7 Participants	12 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 7	0 Participants	4 Participants	7 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 8 - Very Severe Pain	1 Participants	8 Participants	5 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 9	0 Participants	0 Participants	0 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 1-Month Follow Up · 10 - Worst Possible Pain	2 Participants	2 Participants	4 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 0 - No pain	12 Participants	14 Participants	9 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 1	11 Participants	10 Participants	11 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 2 - Mild Pain	25 Participants	18 Participants	24 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 3	14 Participants	10 Participants	10 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 4 - Moderate Pain	22 Participants	24 Participants	26 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 5	7 Participants	11 Participants	19 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 6 - Severe Pain	5 Participants	13 Participants	5 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 7	2 Participants	2 Participants	4 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 8 - Very Severe Pain	3 Participants	1 Participants	5 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 9	0 Participants	0 Participants	1 Participants
Pain Intensity Numeric Rating Scale (PI-NRS). 3-Month Follow Up · 10 - Worst Possible Pain	4 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: It will be administered at baseline and the 1-month and 3-month follow-ups.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Pain Sensitivity Index (PSI; Gross, 1992a). Baseline	67.3 score on a scale Standard Deviation 23.2	68.4 score on a scale Standard Deviation 21.6	68.4 score on a scale Standard Deviation 24.0
Pain Sensitivity Index (PSI; Gross, 1992a). 1 Month	58.6 score on a scale Standard Deviation 24.3	63.2 score on a scale Standard Deviation 23.3	62.8 score on a scale Standard Deviation 25.1
Pain Sensitivity Index (PSI; Gross, 1992a). 3 Months	55.3 score on a scale Standard Deviation 26.5	56.9 score on a scale Standard Deviation 23.9	57.9 score on a scale Standard Deviation 25.5

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Distress Tolerance Scale (DTS; Simons & Gaher, 2005). Baseline	45.6 score on a scale Standard Deviation 12.8	44.9 score on a scale Standard Deviation 12.6	43.7 score on a scale Standard Deviation 14.0
Distress Tolerance Scale (DTS; Simons & Gaher, 2005). 1 Month	47.6 score on a scale Standard Deviation 13.5	46.3 score on a scale Standard Deviation 13.8	46.1 score on a scale Standard Deviation 14.4
Distress Tolerance Scale (DTS; Simons & Gaher, 2005). 3 Months	49.3 score on a scale Standard Deviation 15.0	47.2 score on a scale Standard Deviation 13.7	47 score on a scale Standard Deviation 13.7

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). Baseline	45.6 score on a scale Standard Deviation 12.8	44.9 score on a scale Standard Deviation 12.6	43.7 score on a scale Standard Deviation 14
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). 1 Month	47.6 score on a scale Standard Deviation 13.5	46.3 score on a scale Standard Deviation 13.8	46.1 score on a scale Standard Deviation 14.4
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). 3 Months	49.3 score on a scale Standard Deviation 15.0	47.2 score on a scale Standard Deviation 13.7	47.0 score on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=105 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=108 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). Post-Intervention	27.3 score on a scale Standard Deviation 3.7	27.7 score on a scale Standard Deviation 3.7	—
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). 1-Month	25.9 score on a scale Standard Deviation 4.2	26.8 score on a scale Standard Deviation 4.3	—
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). 3-Months	26.4 score on a scale Standard Deviation 4.8	27.4 score on a scale Standard Deviation 4.3	—

SECONDARY outcome

Timeframe: baseline assessment, and at one- and three-month follow-ups.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=154 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=156 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=167 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Change in Distress and Interference Rating From the ADIS-5 Baseline	4.6 score on a scale Standard Deviation 1.6	4.5 score on a scale Standard Deviation 1.7	4.3 score on a scale Standard Deviation 1.7
Change in Distress and Interference Rating From the ADIS-5 1 Month	4.0 score on a scale Standard Deviation 1.6	3.9 score on a scale Standard Deviation 1.6	3.7 score on a scale Standard Deviation 1.6
Change in Distress and Interference Rating From the ADIS-5 3 Month	3.9 score on a scale Standard Deviation 1.6	3.6 score on a scale Standard Deviation 1.8	3.4 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: baseline assessment, and at one- and three-month follow-ups.

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.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=154 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=156 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=167 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Change in Percentage of Dentally Phobic Patients From the ADIS-5 Baseline	131 Participants	130 Participants	140 Participants
Change in Percentage of Dentally Phobic Patients From the ADIS-5 1 Month	72 Participants	73 Participants	84 Participants
Change in Percentage of Dentally Phobic Patients From the ADIS-5 3 Month	61 Participants	57 Participants	72 Participants

SECONDARY outcome

Timeframe: 1 year post-dental anxiety intervention

Population: 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

We will utilize TUKSoD's automated scheduling system (axiUm, http://www.axiumdental.com/) to collect information about dental attendance.

Outcome measures

Outcome measures
Measure	Psychology Intervention n=162 Participants Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 Participants Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 Participants These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Change in Attendance at Dental Appointments Appointments No Showed (Pre-Intervention)	0.6 Number of Appointments Standard Deviation 1.0	0.6 Number of Appointments Standard Deviation 1.0	0.7 Number of Appointments Standard Deviation 1.1
Change in Attendance at Dental Appointments Appointments Completed (Pre-Intervention)	6.2 Number of Appointments Standard Deviation 5.3	5.7 Number of Appointments Standard Deviation 4.6	6.2 Number of Appointments Standard Deviation 5.0
Change in Attendance at Dental Appointments Pre-Completion Rate (Pre-Intervention)	0.8 Number of Appointments Standard Deviation 0.2	0.8 Number of Appointments Standard Deviation 0.2	0.8 Number of Appointments Standard Deviation 0.2
Change in Attendance at Dental Appointments Appointments Cancelled (Pre-Intervention)	1.3 Number of Appointments Standard Deviation 1.9	1.3 Number of Appointments Standard Deviation 1.9	1.2 Number of Appointments Standard Deviation 1.5
Change in Attendance at Dental Appointments Appointments No Showed (Post-Intervention)	0.8 Number of Appointments Standard Deviation 1.2	0.6 Number of Appointments Standard Deviation 1.1	0.9 Number of Appointments Standard Deviation 1.3
Change in Attendance at Dental Appointments Appointments Completed (Post-Intervention)	5.4 Number of Appointments Standard Deviation 5.8	5.2 Number of Appointments Standard Deviation 5.3	4.6 Number of Appointments Standard Deviation 4.6
Change in Attendance at Dental Appointments Post-Completion Rate (Post-Intervention)	0.6 Number of Appointments Standard Deviation 0.3	0.6 Number of Appointments Standard Deviation 0.3	0.6 Number of Appointments Standard Deviation 0.3
Change in Attendance at Dental Appointments Appointments Cancelled (Post-Intervention)	1.7 Number of Appointments Standard Deviation 1.9	1.6 Number of Appointments Standard Deviation 1.9	1.5 Number of Appointments Standard Deviation 1.6

Adverse Events

Psychology Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dental Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Psychology Intervention n=162 participants at risk Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows)	Dental Intervention n=167 participants at risk Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants).	Control n=170 participants at risk These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video.
Psychiatric disorders Increased anxiety post-intervention	0.00% 0/162 • From Baseline to 3-month follow up, around 12 weeks Adverse events for this study adhere to the definition provided by ClinicalTrials.gov	0.60% 1/167 • Number of events 1 • From Baseline to 3-month follow up, around 12 weeks Adverse events for this study adhere to the definition provided by ClinicalTrials.gov	0.00% 0/170 • From Baseline to 3-month follow up, around 12 weeks Adverse events for this study adhere to the definition provided by ClinicalTrials.gov

Additional Information

Associate Dean for Research & Chair Department of Oral Health Sciences

Temple University Kornberg School of Dentistry

Phone: 215-707-1773

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place