Efficacy of an Internet-based Intervention for Dental Anxiety
Phase: NA
Conditions: Dental Anxiety
Sponsor: Temple University

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1) Abstract of the study 
This protocol describes activities that are a part of a clinical trial grant (U01) application 
by the investigators to the National Institute of Dental and Craniofacial Research 
(NIDCR) examining an internet-based cognitive-behavioral treatment (I-CBT) for 
patients of the Temple University Kornberg School of Dentistry (TUKSoD) who suffer 
from significant dental anxiety. This is a 5-year clinical trial that will evaluate the efficacy 
of a brief I-CBT for the treatment of impairing dental anxiety among those seeking 
dental care at the clinics of TUKSoD.  
 
The study will be a randomized controlled trial in which patients seeking services at the 
TUKSoD Faculty Practice Clinic who screen positive for dental anxiety will be provided 
with I-CBT under the supervision of psychology clinicians highly trained in CBT 
techniques versus dental assistants with minimal training designed specifically to 
prepare them to supervise the delivery of the I-CBT protocol to anxious dental patients. 
Patients (N=550) will be randomized to one of these two arms of the study or to a third 
(control) arm in which participants will be asked to view a video of nature scenes for a 
period of time equivalent to the dental anxiety intervention. The dental care provider for 
all participants will also be informed of their scores on the dental anxiety screening 
measure. Demonstration of relatively equivalent efficacy of the I-CBT treatment when 
provided by dental assistants versus more highly trained psychology personnel will 
facilitate the dissemination of I-CBT for dental anxiety to dental offices in a sustainable 
way that would allow greater access for a larger number of potential patients with dental 
anxiety. 
 
Initial assessments will be conducted in the few weeks preceding patients’ already-
scheduled appointments for dental treatment at TUKSoD. Patients meeting inclusion 
and exclusion criteria will then be offered I-CBT or the control intervention, to occur 
immediately prior to their scheduled dental treatment appointment. Efficacy based on 
primary outcome measures (e.g., reduction from baseline on self-rated and clinician-
rated measures of dental anxiety/fear) and secondary outcome measures will be 
examined at assessments one and three months thereafter. Some additional interview 
ratings will be gathered from patients after they complete the dental anxiety 
intervention and after they complete the pursuant dental treatment appointment, and 
one brief questionnaire will be administered six and twelve months later. Finally, we 
will examine the impact that the intervention may have on attendance at scheduled 
dental appointments over the next 12 months.  
 
2) Protocol Title 
Efficacy of an Internet-based intervention for dental anxiety  
  
3) Investigators  

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Marisol Tellez, PhD, Associate Professor, Chair, and Residency Director, Pediatric 
Dentistry and Community Oral Health Sciences, Maurice H. Kornberg School of 
Dentistry, Temple University 
Eugene Dunne, PhD, Assistant Professor, Department of Oral Health Sciences, 
Maurice H. Kornberg School of Dentistry, Temple University 
 
4) Objectives 
The primary goal 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 goal, we propose 3 
primary objectives:  
 
Objective 1: We will compare the efficacy of I-CBT as administered by personnel with 
training and experience in CBT to the efficacy of the intervention as administered by 
dental assistants who have undergone a brief but specific training in the administration 
of the intervention, a goal which would allow the greater dissemination of this 
intervention. We will also examine within-group reduction of anxiety at assessments 
one and three months after the administration of the intervention.  
 
Objective 2: We will compare the efficacy of the intervention, administered either by 
CBT personnel or dental staff, to an active control condition, the viewing of the control 
video and the notification of the dental provider of the patient’s score on a measure of 
dental anxiety before the dental appointment.  
 
Objective 3: We will examine the impact that the intervention has on attendance at 
scheduled dental treatment appointments over the next 12 months. 
Secondary Objectives:   
We will examine whether I-CBT has similar effects on related measures (pain sensitivity, 
anxiety sensitivity, distress tolerance, symptoms of specific phobia of dental procedures, 
blood-injury-injection phobia, sleep disturbance and sleep-related impairment, 
functional impairment due to dental anxiety, and consumer satisfaction) at one- and 
three-month follow-ups. 
We will also examine whether the Internet-based intervention reduces anticipated and 
perceived pain and anxiety during dental procedures in immediately pursuant 
appointments for dental treatment.   
We will also examine whether baseline levels of distress tolerance and pain sensitivity 
moderate the efficacy of the dental anxiety intervention. 
 
5) Rationale and Significance  

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Dental anxiety (i.e., anxiety related to undergoing dental procedures) is a major public 
health concern, as it leads to underutilization of dental care and poor oral health. 
Approximately 10-20% of individuals in the US endorse significant dental anxiety, and 
10-50% cancel regular dental care appointments or delay treatment for a painful dental 
condition due to fears of dental procedures (Sohn & Ismail, 2005). Patients with dental 
anxiety are more likely to be referred for nitrous oxide sedation (Boyle, Newton, & 
Milgrom, 2009) and use emergency dental services (Kanegane, Penha, Borsatti, & 
Rocha, 2003), both of which increase individual and public dental healthcare costs. 
Dental anxiety has been consistently associated with increased oral health problems 
and impairment (e.g., more cavities; Armfield, Stewart, & Spencer, 2007). Few studies 
have examined the efficacy of psychological treatments for dental anxiety (Gordon, 
Heimberg, Tellez, & Ismail, 2013), and most of the existing empirically supported 
psychological interventions cannot be easily disseminated within dental healthcare 
settings, as they must be administered by highly trained clinicians over a number of 
sessions. Therefore, it is the goal of our ongoing research program to develop a brief 
online therapy for dental anxiety that could be easily implemented in dental clinics, 
allowing for broader dissemination. 
Dysfunctional thoughts about dental treatment are central to dental anxiety (Armfield & 
Heaton, 2013). Many anxious patients think that dental treatment will be extremely 
painful, that something catastrophic will go wrong during treatment, that the dentist will 
make a mistake, and that the dentist or others will be judgmental about the state of 
one’s oral health (De Jongh, Muris, Schoenmakers, & Horst, 1995; Moore, Brødsgaard, 
& Rosenberg, 2004). High physiological arousal is also prominent in dental anxiety. 
Dental anxiety is positively associated with elevated heart rate, blood pressure, and 
cortisol levels during dental procedures (Brand, Gortzak, & Palmer-Bouva, 1995). 
Patients with dental anxiety often delay or avoid dental treatment, which can cause 
dental problems that require invasive treatment, and, in turn, lead to the maintenance or 
exacerbation of dental anxiety (Armfield et al., 2007).  
CBT techniques are efficacious at reducing dental anxiety and avoidance among adult 
patients acutely and at follow-up (Gordon et al., 2013). Repeated, graduated exposure 
to feared dental procedures is a key component of CBT for dental anxiety (Gordon et 
al., 2013). Cognitive techniques, relaxation, and the provision of detailed information 
about dental procedures meant to increase patients’ sense of control over dental care 
also appear to reduce dental anxiety and avoidance (Gordon et al., 2013). Although 
CBT has consistently demonstrated efficacy at managing dental anxiety and dental 
phobia, rates of dental treatment avoidance have seen only a slight reduction, anxiety 
treatment is underutilized, and the prevalence of dental anxiety remains high (Choy, 
Fyer, & Lipsitz, 2007). A major reason that CBT for dental anxiety has not been widely 
disseminated is that most existing therapy protocols require delivery by a highly trained 
professional (Gordon et al., 2013). The development of brief, easily disseminated CBT 
interventions is an important step toward combating dental anxiety and reducing its 
public health costs.  
Computerized or online CBT offers promise as a practical, and potentially efficacious, 
modality for dental anxiety treatment. Computerized CBT protocols have demonstrated 
efficacy comparable to conventional CBT in the treatment of mood (e.g., Berger, 

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Hämmerli, & Gubser, 2011; Christensen, Griffiths, & Jorm, 2004) and anxiety disorders 
(e.g., Hedman, Andersson, Ljótsson, & Andersson, 2011; Wims, Titov, & Andrews, 
2010). One recently published randomized controlled trial found that a computerized 
exposure-based therapy for dental injection fear reduced self-reported injection-specific 
dental anxiety when compared to a control group receiving a psychoeducational 
pamphlet (Heaton, Leroux, Ruff, & Coldwell, 2013). However, the intervention only 
targeted dental injection fear. Therefore, further empirical investigation of 
computerized/online therapy interventions for dental anxiety, as well as development of 
interventions that address anxiety related to a broad array of dental procedures, are 
needed. We have developed such an experimental intervention and hope to continue its 
evaluation in this clinical trial. 
A single-session computer-based 60-minute CBT intervention has been developed by 
our group over the last few years, which is administered to patients immediately in 
advance of an appointment for dental care. It consists of psychoeducation, considering 
the benefits/drawbacks of working on dental anxiety, cognitive restructuring skills, and 
graduated exposure to feared dental procedures. It begins with the psychoeducation 
module, during which the patient is provided with basic education about the nature of 
anxiety, with an emphasis on dental anxiety. The psychoeducation module reviews 
anxiety-related topics such as understanding the physiological, cognitive, and 
behavioral (e.g., avoidance) components of anxiety; how anxious thoughts can be 
reframed into coping thoughts; rating one’s subjective level of anxiety; and the rationale 
behind exposure to feared situations. These topics are specifically connected to anxiety 
about dental procedures, and patients are also provided with information about the 
presence and typical manifestation of dental anxiety. Next, patients are guided through 
a decisional balance exercise that helps them consider the benefits and drawbacks of 
learning to cope with their dental anxiety.  
Thereafter, patients are guided through the exposure exercises, which are 
supplemented with opportunities to learn and practice cognitive restructuring skills. First, 
patients are asked to select their three most feared procedures from a list of six types of 
dental procedures (drilling and having a cavity filled, typical cleaning, anesthetic 
injection, root canal, oral X-ray, and tooth extraction) and rank the three procedures 
from least to most anxiety-provoking. Patients then watch videos of their feared 
procedures, starting with the least anxiety-provoking and working up to the most 
anxiety-provoking. For each selected procedure, three videos, each about 4 minutes 
long, are presented: (1) The first video depicts a dentist and/or hygienist simulating the 
procedure with an actor playing the role of a patient. Animations of aspects of the 
procedure that occur within the mouth are included, as are close-ups of the dental tools 
employed. The voiceover explains the basics of the dental procedure, including how the 
dental tools are used. This video is intended to help the participating patient develop a 
greater sense of control over what is happening to him/her in the dental chair by 
providing increased knowledge about the procedure. (2) The second video presents 
similar visuals of the dental procedure, but is more focused on the patient’s face and 
his/her emotional experience during the procedure. The voiceover presents a dialogue 
between the narrator and the patient as if it were occurring in the patient’s head; they 
discuss the patient’s negative thoughts and the tools of cognitive restructuring applied to 
these thoughts. This video provides a second exposure to the feared procedure and 

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basic training in the nature and use of cognitive coping skills. (3) The third video was 
filmed from the perspective of a patient in the dental chair and provides additional and 
more intensive exposure to the feared dental procedure. The voiceover is a “dialogue” 
between the acting patient in the video, who presents cognitive coping from a self-
administered/self-help perspective, and the participating patient, who is led through the 
steps to develop coping thoughts to counter his/her own anxious thoughts. The 
intervention closes with a brief module providing additional motivational enhancement 
for attending future dental appointments. Upon completing the intervention, patients 
attend their scheduled dental appointment and are encouraged to use the skills they 
learned from the intervention to cope with any anxiety they experience during that 
appointment. 
The computer-based intervention was piloted on a sample of six dental patients from 
the TUKSoD Clinics (Potter et al., 2016). All patients completed the experimental 
intervention and attended their appointment for dental care, and 5/6 were contacted and 
re-assessed after one month. Three patients demonstrated clinically significant 
reductions in dental anxiety, and the remainder demonstrated lesser improvements. We 
next conducted a randomized controlled trial of the experimental intervention in 
comparison to a waitlist control condition (N = 151; Tellez et al., 2015).  The computer-
based intervention resulted in greater declines in dental anxiety, and clinician ratings of 
dental fear and avoidance were also markedly reduced. Among those who met criteria 
for dental phobia at baseline, a larger percentage of treated patients no longer did so 
after the treatment interval than was the case for patients assigned to the waitlist 
condition. Patients who received this computerized dental anxiety intervention reported 
high levels of satisfaction (83% were “very satisfied”). 
We have converted this computer-based intervention to one that can be administered 
online. In terms of content, it is identical to the intervention described above, but it is no 
longer dependent on its being resident on the hard drive of a specific computer. In our 
previous R34 planning grant (a smaller grant required by the NIDCR before an 
investigator can apply for a full-scale clinical trial grant), one of our objectives was to 
determine the feasibility and acceptability of this more accessible but less tested form. 
Findings from the planning grant indicated that this online intervention was indeed 
acceptable and feasible as administered by psychology personnel to patients attending 
dental appointments at TUKSoD. It was also the case that before the planning grant, the 
intervention, while efficacious, had only been administered with the assistance of 
psychology doctoral students or post-baccalaureate research assistants, all of whom 
were quite knowledgeable about cognitive-behavioral interventions and treatments for 
anxiety disorders more generally and who were highly trained in the administration of 
this protocol. We saw this as a barrier to the intervention’s ultimate adoption or 
dissemination into dental offices.  Findings from the planning grant suggested that the 
online intervention was equally efficacious when in the hands of dental assistants who 
were trained for the specific task but who lacked the depth of background knowledge 
about psychological treatments in general. 
In the current trial, we aim to extend these findings by examining the efficacy of I-CBT 
as administered by psychology personnel compared with dental personnel in a larger 
sample of 550 patients. We also aim to evaluate whether the I-CBT, as administered by 

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both psychology and dental personnel, is better than an active control condition. We 
hypothesize that I-CBT will have a stronger impact on dental anxiety than the active 
control condition. We also hypothesize that the intervention will be as efficacious when 
delivered by dental assistants who have undergone a brief but specific training in the 
administration of the intervention as it is when administered by personnel with 
experience in CBT based upon prior research on Internet-based interventions for other 
disorders (Shandley et al., 2008) and our small-scale open trial conducted as part of the 
R34 project. 
  
6) Resources and Setting  
The human subjects activities for this clinical trial will take place at TUKSoD. Patients 
with dental anxiety will be recruited from the TUKSoD Faculty Practice Clinic (If it 
appears that we will fall short of enrollment milestones, additional patients will be 
recruited from among those receiving dental treatment at the Graduate Clinics of 
TUKSoD: Endodontology, Periodontology, and Advanced Education General Dentistry. 
See attached letters from the Directors of these clinics.). The administration of the 
online dental anxiety intervention will take place in the Center for Public Health 
Research (CPHR) of TUKSoD, which is the research laboratory of one of the study 
investigators, Dr. Tellez. This is precisely the arrangement that was utilized in the 
conduct of the randomized controlled trial (Tellez et al., 2015) and in the R34 planning 
grant described above.  
Beyond CITI training, all psychology personnel involved in the human subjects aspects 
of the current protocol will be highly trained in the relevant activities, which involve the 
administration of the online dental anxiety intervention, administration of interviews and 
questionnaires, conducting screening/assessment/follow-up phone calls, and the 
management of data. Psychology personnel will either (1) have been members of the 
research team for the previous clinical trial, for which most procedures will be quite 
similar and will have received training and practice with non-patient research assistants 
acting as patients in the specific details of the operation of the program, or (2) they will 
be persons of similar levels of training (postdoctoral fellows in clinical psychology, staff 
psychologists, or advanced clinical psychology doctoral students). Most of the treatment 
in service of the first objective will be administered by a postdoctoral fellow or clinical 
psychology doctoral student. Other research assistants who currently conduct 
solicitation calls for ongoing studies of dental anxiety will do so for the proposed 
protocol as well. 
A post-baccalaureate study coordinator with a background in psychology or a related 
field will perform many important tasks for the U01 project. After appropriate training, the 
study coordinator will conduct the bulk of the initial telephone screening interviews. 
He/she will also conduct diagnostic interviews at baseline and one-month and three-
month follow-up assessments and track attendance at scheduled dental appointments 
for the 12-month period following the dental anxiety intervention. He/she will also 
complete reliability ratings for diagnostic interviews conducted by other study staff, 
providing full coverage of this activity with the graduate student. The study coordinator will 
also be charged with the rating of treatment fidelity/adherence of a portion of the 

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interventions completed during the U01 project. The study coordinator will also conduct a 
range of data entry and management activities. 
 
The dental staff for the proposed U01 will be two or more part-time dental assistants or 
expanded function dental assistants as defined in the State of Pennsylvania working with 
Dr. Tellez at TUKSoD (one full-time equivalent). They will be trained in the administration 
of the Internet-based dental anxiety intervention by a psychologist, postdoctoral fellow, 
or doctoral student highly trained in CBT and the specific online intervention, and they 
will administer the dental anxiety intervention to those patients randomly assigned to the 
arm of the trial in which the intervention is delivered by dental staff. They will also assist 
in the payment of study subjects and other day-to-day tasks when these activities 
cannot be performed by the post-baccalaureate study coordinator. 
 
7) Prior Approvals 
See attached letters of support from the Directors of the Faculty Practice Clinic and the 
Graduate Clinics of TUKSoD. 
 
8) Study Design 
a) Recruitment Methods 
Approximately 550 patients will participate in this research, roughly evenly divided 
between the three arms of the study.  
Participants will be patients who have scheduled an appointment for non-emergent 
dental care at the Faculty Practice Clinic at TUKSoD (recruitment will be expanded to 
include the Graduate Clinics if needed to meet recruitment milestones). All such 
persons’ names and telephone numbers will be entered into the Faculty Practice Clinic’s 
scheduling software as part of standard operating procedure, and the study coordinator 
will have access to this information. Potential participants will be contacted by telephone 
and asked if they would be willing to be screened for dental anxiety and, if so, if they 
would be interested in the possibility of participating in a study of the treatment of dental 
anxiety (See attached “Guidelines for Introducing the Study”). In addition to contacting 
patients who are already in the dental school scheduling software, we will also display 
study materials in the waiting area of the clinic. Fliers containing contact information and 
a brief description of the study will be displayed on waiting area tables and posted at 
available locations within the clinic. Small cards with a brief description and contact 
information will also be available for patients to take with them. This will provide the 
opportunity for patients to reach out to research staff directly to express interest in 
participating. Recruitment materials will also be made available within the clinic offices 
where patients receive their dental care. Dental care providers may hand a patient an 
information card, but will not explain the study or actively recruit the patient. Providers 
will be instructed to direct any patients questions to the study coordinator or other 
research study staff. Approved study staff will periodically make rounds through the 
waiting areas of clinics that are being actively recruited from. They will greet participants 

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and follow an approved script to gauge interest and provide a brief overview of the 
research study. If interested in participating, patients can reach out to study staff directly 
via phone or email. Additionally, if participants prefer to be contacted directly, they can 
provide their information via a contact form. Information will be collected on a separate 
form for each patient, rather than a running list, to maintain the privacy and personal 
information of interested patients. All recruitment methods will utilize the same 
screening process and eligibility requirements for study enrollment.   
If the potential patient responds that they would not be interested, the interviewer will 
thank the patient for his/her time and terminate the call. If the patient responds 
affirmatively (i.e., gives verbal consent for the brief screening), the interviewer will first 
ask one screening question (age) and then administer the Modified Dental Anxiety 
Scale (Humphris et al., 1995), which is the primary screening measure of dental anxiety 
employed in this study (see attached measures file for specific questions). The 
interviewer will also ask whether the patient experiences impairment as a result of 
dental anxiety. If the patient fails to meet these screening criteria or appears to be 
insufficiently fluent in English, the interviewer will thank the patient for his/her time and 
terminate the call. If the patient meets criteria for dental anxiety and impairment, the 
interviewer will then administer the Medical Screening Interview, and if the patient 
meets any exclusion criterion based on that interview, the call will be similarly 
terminated. If not, the interviewer will provide more extensive information about the 
study and the risks and benefits of study participation (see attached “Summary Consent 
Script to be Read During Screening Phone Call”), and verbal consent for full study 
participation will be obtained. If the patient is still willing and appears to meet 
inclusion/exclusion criteria as outlined above, he/she will be scheduled for a second 
(“pre-intervention” or “baseline”) interview and questionnaire administration. Patients will 
be randomized to one of three arms as described above. 
To assist in recruitment and retention, we will focus on strategies that we utilized in our 
recently completed randomized controlled trial for the computer-based version of the 
intervention and others that we believe to be useful based on that experience with the 
same patient population. These will include reminder calls and text messages the week 
before, the day before, and the day of appointments as well as patient payments for 
completion of assessments ($75 for completion of screening/baseline assessments and 
initiation of the in-clinic visit, $50 for completing each of the follow-up assessments). We 
will coordinate closely with the front office staff of the Faculty Practice Clinic in assuring 
that we are fully aware of patient-initiated schedule changes and to minimize the 
likelihood that the dental treatment appointment will not be pushed back or rescheduled 
by the dental treatment staff without advance notice (an issue that arose at times in the 
conduct of the trial of the computer-based version of the intervention). 
 
Inclusion and Exclusion Criteria 
Inclusion criteria will require that the patient endorse high dental anxiety (a total score of 
19 or a score of 4-5 on at least 2 of the 5 items) on the Modified Dental Anxiety Scale 
(Humphris et al., 1995), endorse at least mild impairment as a result of that anxiety at 
the screening interview, be between 18 and 75 years of age, and be sufficiently fluent in 

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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 are the following: (a) a self-reported currently uncontrolled medical 
condition (e.g., heart attack, seizure disorder) that might make exposure to anxiety-
evoking stimuli inadvisable; or (b) inability to give informed consent. Participants will not 
be excluded on the basis of gender, ethnicity/race, or other demographic 
characteristics, nor will they be required to meet criteria for a formal diagnosis of dental 
phobia. 
b) Study Timelines 
• This clinical trial will last for a period of 5 years 
• The first 6 months will be devoted to recruitment and training of staff.  
• Patient recruitment is estimated to take up to 45 months, with the final 
enrollee completing follow-ups 3 months later (and monitoring of their 
attendance at dental appointments continuing for 9 additional months).  
• Participants will complete assessments at baseline, day of intervention, and at 1-
month, 3-month, 6-month, and 12-month follow-ups. Total participation time for each 
patient is approximately 12 to 13 months but could be slightly longer pending the 
interval between screening/baseline and the scheduled date of the dental anxiety 
intervention/dental appointment. Only brief (5-item) assessments will be conducted 
at 6- and 12-month follow-ups. 
• The last six months will be devoted to major data analyses and the preparation of 
manuscripts in addition to the ongoing monitoring of attendance at dental 
appointments. 
• The date of the award was August 1, 2018, and we hope to have completed all 
activities by July 31, 2023. 
c) Study Procedures and Data Analysis 
 
Study Schedule 
 
Screening (Time 0) 
Until we have ascertained our sample, all patients who have scheduled appointments 
for non-emergent dental procedures through the TUKSoD Faculty Practice Clinic will be 
contacted by research staff, who will briefly explain the purpose of the study and obtain 
verbal consent to conduct a brief dental anxiety and medical screening (See attached 
“Guidelines for Introducing the Study”). If the potential patient responds that they would 
not be interested, the interviewer will thank the patient for his/her time and terminate the 
call. If the patient responds affirmatively, the interviewer will first ask one screening 
question (age) and then administer the Modified Dental Anxiety Scale (Humphris et al., 
1995) and ask whether the patient experiences impairment as a result of dental anxiety. 
If the patient fails to meet these screening criteria or appears to be insufficiently fluent in 
English, the interviewer will thank the patient for his/her time and terminate the call. If 
the patient meets criteria for dental anxiety and impairment, the interviewer will then 

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administer the Medical Screening Interview, and if the patient meets any of the 
exclusion criteria based on that interview, the call will be similarly terminated. If not, the 
interviewer will provide more extensive information about the study and the risks and 
benefits of study participation (see attached “Summary Consent Script to be Read 
During Screening Phone Call”), and verbal consent for full study participation will be 
obtained. If the patient remains interested, he/she will then be offered the opportunity to 
schedule an appointment for the pre-intervention assessment session. Note that 
recruitment will be expanded to include the TUKSoD Graduate Clinics [Endodontology, 
Periodontology, Advanced Education General Dentistry] if needed to achieve enrollment 
milestones. 
 
Enrollment/Baseline (Time 1) 
The interviewer will administer the specific phobia module of the Anxiety and Related 
Disorders Interview Schedule for DSM-5 (ADIS-5) - Adult Version (Brown & Barlow, 
2014). Questionnaires specified in Table 1 (Measures and Timing of Their 
Administration) will also be administered by the interviewer over the phone. 
Alternatively, for those patients with Internet access and who prefer to use it, the 
questionnaires can be completed online through the use of an online data collection 
service. 
Senior research staff will administer the randomization of participants (computer 
generated). The file will be secured and restricted to the time of randomization. 
Randomization will be done after the patient has received the consent summary, all 
baseline assessments are completed, and there are no further concerns about 
exclusion criteria. At that time, the study coordinator will be instructed to make an 
appointment for the Clinic Visit (Time 2), but the patient’s randomization condition will 
not be revealed until the patient has arrived at the clinic and in-person informed consent 
procedures are completed. 
 
Intermediate Visits (Times 2 and 3) 
A more thoroughly detailed version of the consent form used during the initial telephone 
contact will be given to the patient on his/her arrival for the Time 2 appointment, any 
further questions will be addressed.  Electronic informed consent will be obtained at that 
time using Adobe Acrobat. An electronically signed copy of the consent form will be 
provided to the patient via email, and another signed copy will be placed in the patient’s 
research record. The dental anxiety intervention will then be administered (or filler 
activities will be completed for active control participants). Immediately upon the 
completion of the intervention and immediately after the completion of the following 
scheduled dental appointment (Times 2 and 3, respectively), debriefing interviews will 
be administered. These are described in the section on Study Procedures/Evaluations 
below.  
 
Follow-up Visits (Times 4 and 5) 
Time 4 is the follow-up contact one month (i.e., 4-5 weeks) after the day of the dental 
anxiety intervention and the scheduled dental appointment. This is the first opportunity 
for an in-depth follow-up assessment, and the full list of assessments administered at 

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the pre-intervention assessment session will be re-administered. This includes the 
ADIS-5 interview, amended to include some debriefing questions as described above, 
and all questionnaires including the Client Satisfaction Questionnaire (CSQ-8). This 
session will be scheduled as an in-person visit, with both interview and questionnaires 
completed in the research offices. However, if logistical barriers or scheduling difficulties 
arise, the session may be conducted by telephone. In that circumstance, questionnaires 
may be administered over the phone or online.  
 
Time 5 is the follow-up contact three months (12-15 weeks) after the day of the dental 
anxiety intervention and the scheduled dental appointment. The full list of assessments 
administered at the pre-intervention assessment session will be re-administered. This 
includes the ADIS-5 interview, amended to include some debriefing questions as 
described above, and all questionnaires including the CSQ-8. This session will be 
scheduled as an in-person visit, with both interview and questionnaires completed in the 
research offices. However, if logistical barriers or scheduling difficulties arise, the 
session may be conducted by telephone. In that circumstance, questionnaires may be 
administered over the phone or online. This assessment is identical to the one at Time 
4. Brief (5-item) assessments will also be conducted by phone or online at 6- and 12-
month follow-ups. Attendance at dental appointments will continue to be monitored until 
12 months have passed since the day of the dental anxiety intervention. 
 
Study Procedures/Evaluations 
 
A table is provided below which lists the measures to be administered and the timing of 
their administration: 
 
Table 1. Measures and Timing of Their Administration 
Measure 
Initial 
Screen 
Baseline 
Assess-
ment 
Dental 
Anxiety 
Intervention/ 
Index Dental 
Appointment 
1-mo 
Follow-
up 
3-mo 
Follow-
up 
6-mo 
Follow-
up 
12-mo 
Follow-
up 
Modified Dental Anxiety Scale 
X 
X 
 
X 
X 
X 
X 
Medical Screening Interview 
X 
 
 
 
 
 
 
Anxiety and Related Disorders 
Interview Schedule-5 Specific Phobia 
Module 
 
X 
 
X 
X 
 
 
Post-Dental Anxiety Intervention 
Debriefing Interview 
 
 
X 
 
 
 
 
Post-Dental Appointment Debriefing 
Interview 
 
 
X 
 
 
 
 
Pain Intensity Numeric Rating Scale 
 
 
X 
 
 
 
 
Pain Sensitivity Index 
 
X 
 
X 
X 
 
 
Anxiety Sensitivity Index-3 
 
X 
 
X 
X 
 
 
Distress Tolerance Scale 
 
X 
 
X 
X 
 
 
Fear Questionnaire Blood-Injury-
Injection Subscale 
 
X 
 
X 
X 
 
 
PROMIS-Sleep Disturbance-Short 
Form 
 
X 
 
X 
X 
 
 

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PROMIS-Sleep-Related Impairment-
Short Form 
 
X 
 
X 
X 
 
 
Sheehan Disability Scale 
 
X 
 
X 
X 
 
 
Client Satisfaction Questionnaire-8 
 
 
X 
X 
X 
 
 
 
Initial Screening Measures 
 
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 two studies. The MDAS has demonstrated good internal consistency (α = .89 in 
Humphries et al., 1995; α = .91 in our pilot work) and test-retest reliability (r = .82). The 
MDAS will be administered at several occasions throughout the study. We will also 
briefly contact patients and ask them to complete the MDAS by phone or online at 6-
month and 12-month follow-ups as well. 
 
Medical Screening Interview. During the initial telephone screening, we will administer a 
medical screening interview that has been used in previous research by former PI 
Heimberg at Temple University. This medical screening interview assesses a number of 
medical conditions that may make it inadvisable for the potential participant to be 
exposed to anxiety-evoking materials unless well-controlled. If the potential participant 
meets criteria for any of these medical conditions and does not report that they are 
controlled by medication or other appropriate means, that potential participant will be 
excluded. It is also important to note that the Faculty Practice Clinic (the clinic in which 
the trial will be conducted) also conducts it own medical screening and will not schedule 
a patient for an appointment for dental care if the patient scores positive for any of the 
listed conditions on their form unless it is medically controlled (patient will be first 
referred out for appropriate medical care before coming back to the dental clinic when 
the medical condition is controlled). Although the routine clinical procedures of Faculty 
Practice Clinic are not a formal part of our protocol, they are thorough and suggest that 
our procedures are conservative, as we are recruiting only from the population of 
patients for whom an appointment for dental care has already been scheduled. 
 
Other Self-Report Questionnaires 
Note: we will modify the instructions for some questionnaires to refer to the present time 
or the time since the last assessment, depending on when the scale is administered, so 
that the relevant time interval is examined. 
 
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 

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on treatment day and at the 1-month and 3-month follow-ups to patients who received 
the online dental anxiety intervention only. 
 
Anxiety Sensitivity Index-3 (ASI-3: Taylor et al., 2007). The ASI-3 is an 18-item measure 
which assesses the extent to which individuals are concerned about the potential 
negative consequences of anxiety-related symptoms and sensations. The ASI-3 has 
demonstrated high internal consistency (α = .95) and convergent validity with a wide 
range of established anxiety-related measures (Gonzalez et al., 2011). Anxiety 
sensitivity is significantly correlated with fear of pain, and fear of pain predicts increased 
pain, expectation of pain, and avoidance of potentially painful experiences (Ocañez et 
al., 2010). The ASI-3 will be administered at baseline and 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 scale has demonstrated 
high internal consistency in previous studies with dental patients (α = 0.92) (Klages et 
al., 2004). It was found to measure a construct distinct from dental phobia and health 
concerns (Gross, 1992a). Pain sensitivity is considered a stable characteristic that can 
influence the development of situational fears (Gross, 1992b). It has been related to 
dental anxiety and expectation of pain before dental procedures (Klages et al., 2004). 
The PSI will play a dual role in this study, as a secondary outcome measure and as a 
hypothesized moderator of the efficacy of the Internet-based dental anxiety 
intervention compared to the active control condition. 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. This scale has high 
internal consistency (α = .89), appropriate convergence with other self-report ratings of 
affective distress and regulation, and adequate six-month test-retest reliability (r =.61). 
The DTS will also play a dual role in this study, as a secondary outcome measure and 
as a hypothesized moderator of the efficacy of the Internet-based dental anxiety 
intervention compared to the active control condition. It will be administered at baseline 
and the 1-month and 3-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 

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avoid it) to 8 (would always avoid it). Total scores range from 0-40 with higher scores 
indicating greater phobic avoidance. The FQ is sensitive to treatment-induced 
improvements in phobic responding, demonstrates adequate psychometric properties, 
and is a commonly used measure for research on phobias. The FQ-BII is included here 
because of evidence that suggests a modest but significant overlap between dental 
phobia and BII fears (van Houtem et al., 2014). It will be administered at baseline and 
the 1-month and 3-month follow-ups. 
 
PROMIS-Sleep Disturbance-Short Form (PROMIS-SD-S; Yu, Buysse, & Germain, 
2011). The PROMIS Sleep Disturbance Short Form is an 8-item measure that is part of 
the National Institute of Health’s Patient-Reported Outcome Measurement Information 
System (PROMIS) and derived from its original longer version (Buysse et al., 2010). 
The PROMIS-SD-S assesses sleep disturbance over the previous 7 days. All items are 
rated on a 5-point scale. Total raw scores range from 8-40 (which are then converted to 
T-scores), with higher scores indicating greater sleep disturbance. The measure has 
demonstrated good psychometric properties and greater precision than other commonly 
used measures of sleep quality (Yu, Buysse & Germain, 2011). This measure, as well 
as the measure described below, are included here due to evidence that dental anxiety 
is associated with sleep disturbance (Almoznino et al., 2015); we hope to assess the 
association of dental anxiety and sleep-related difficulties in the current study and track 
potential improvements in sleep outcomes following dental anxiety treatment. This 
measure and the measure described below will be administered at baseline and the 1-
month and 3-month follow-ups.  
 
PROMIS-Sleep-related Impairment-Short Form (PROMIS-SRI-S; Yu, Buysse, & 
Germain, 2011). The PROMIS-Sleep-related Impairment-Short Form is an 8-item 
measure that is also part of the PROMIS initiative and derived from its original longer 
version (Buysse et al., 2010). The PROMIS-SRI-S assesses daytime impairment due to 
sleep difficulties over the previous 7 days. All items are rated on a 5-point scale. Total 
raw scores range from 8-40 (which are then converted to T-scores), with higher scores 
indicating greater sleep-related impairment. Like the PROMIS-SD-S, this measure has 
demonstrated good psychometric properties and greater precision than other commonly 
used measures of sleep quality (Yu, Buysse & Germain, 2011).  
 
Sheehan Disability Scale (SDS; Sheehan,1983). The SDS is a 3-item measure of 
functional impairment due to one’s illness in 1) work, 2) social life, and 3) family/home 
life. Three items assessing each of these domains are rated on a 0 (no impairment) to 
10 (extreme impairment) scale which are then summed and used to assess overall 
current levels of disability due to illness. In the current study, we modified the scale to 
specifically assess the current impact of participants’ dental anxiety symptoms on 
work/school, social life/leisure activities, and family life/home responsibilities. The 
validity and reliability of the SDS has been previously demonstrated among individuals 
with panic disorder (Leon et al, 1992) and social anxiety disorder (Hambrick et al., 
2004). The SDS will be utilized as a secondary outcome measure in the current study to 
assess the degree of functional impairment associated with dental anxiety as well as 

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improvements in functional impairment following the intervention. This measure will be 
administered at baseline and the 1-month and 3-month follow-ups.  
 
Clinician-Administered Interviews 
 
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) - Adult Version 
(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. The ADIS has been utilized in former PI Dr. Heimberg’s research on 
anxiety disorders since it was originally created at the Center for Stress and Anxiety 
Disorders, University at Albany, SUNY, where he was on staff, and he has overseen the 
training of many doctoral students in clinical psychology in its use in the last 30 years. 
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 as well as resultant interference (the latter 
being used to operationalize one of the inclusion criteria). 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. All interviews will be audio-recorded. A 20% sample will be 
randomly selected for assessment of inter-rater agreement on the presence of dental 
phobia and clinical severity. Interviewers have demonstrated excellent inter-rater 
agreement for the principal diagnosis of specific phobia in a mixed sample of anxiety 
disorder patients (κ = .86; Brown et al., 2001). The ADIS-5 module will be administered 
at baseline and the 1-month and 3-month follow-ups. 
 
Post-Appointment Debriefing Ratings. Two separate sets of interview questions will be 
administered, one after the completion of the dental anxiety intervention and the other 
after completion of the following dental appointment. The debriefing interview after the 
dental anxiety intervention will ask the patient to rate the perceived helpfulness of 
each component of the intervention, the degree to which any of the components were 
hard to understand, and the degree of difficulty they experienced watching each set of 
videos of dental procedures. It will also include an open-ended probe of patients’ 
reactions to any aspect of the dental anxiety intervention. These questions will be 
asked for the purpose of collecting qualitative data on patients’ reactions to the 
intervention, to determine whether there are differences between patients assisted by 
psychology versus dental staff, and to gather information to inform future modifications 
of the intervention. Questions will also be asked to determine the degree of pain and 
the degree of anxiety patients expect to experience in the dental treatment 
appointment they will have immediately following the dental anxiety intervention. 
Because this interview will not be administered to patients randomized to the active 
control condition, the ratings of expected pain and anxiety will be administered to them 
after they watch the control video. 
 
Ratings after the dental appointment will assess the degree of pain and anxiety 
experienced during the appointment, the degree of pain and anxiety in comparison to 
past dental appointments, how much the dental anxiety intervention helped the patient 

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to get through the dental procedure (for the full intervention and the major 
components), and the likelihood of scheduling a dental appointment in the future. The 
debriefing interview after the dental appointment will also include an open-ended 
probe of patients’ thoughts about the impact that any aspect of the dental anxiety 
intervention may have had on their reactions to the dental procedure. An abbreviated 
version of this interview will be administered to active control patients, asking about 
pain and anxiety, and omitting any questions related to the dental anxiety intervention. 
 
Pain Intensity Numeric Rating Scale (PI-NRS). The PI-NRS is a widely utilized 11-point 
measure that assesses physical pain intensity on a scale ranging from 0 (no pain) to 10 
(worst possible pain). The PI-NRS has been used to assess pain intensity in several 
studies conducted in medical settings (Farrar et al., 2001, 2010; Rowbotham et al., 
2004; van der Roer, 2006). Anxiety increases subjective pain experience, and therefore 
this scale will be used to assess the intensity of dental related pain that participants 
experienced during their scheduled dental appointment and expect to experience at 
their next dental appointment.  The PI-NRS will be administered as part of the post-
dental-appointment debriefing interview. 
 
Attendance at Dental Appointments 
Given that avoidance of dental appointments is strongly connected to dental anxiety, 
we will also assess whether the Internet-based dental anxiety intervention increases 
attendance at future dental appointments. We will utilize TUKSoD’s automated 
scheduling system (axiUm, http://www.axiumdental.com/) to do so. It is acknowledged 
that attendance may be influenced by factors unrelated to dental anxiety, but it is a 
reasonable hypothesis that anxious avoidance plays a role in attendance, and 
individuals with dental phobia are less likely to visit a dentist at least once a year than 
persons without. Thus, it is of interest to determine whether attendance at 
appointments scheduled prospectively after the index appointment is affected by 
treatment, and we will monitor this for the following 12-month interval. These data will 
not be collected for active control patients, who will be offered the intervention to be 
administered before their first scheduled dental appointment after the completion of 
the 3-month follow-up. 
 
Planned Analyses  
We propose general statistical analyses and sample size considerations for the U01 
trial. Initial analyses will be conducted to determine normality of distributions of the 
continuous variables, and any necessary transformations will be conducted. Primary 
outcomes will be the MDAS (score ranging from 5 to 25) and the rating of fear of 
dental procedures from the ADIS-5 (0=no fear to 8=very severe fear). All eligible 
patients will be randomly assigned to one of the three conditions described above. 
Although randomization should provide relatively comparable groups, demographic 
variables that differ between groups and are correlated with the primary outcomes will 
be used as covariates. Patients will receive a full battery assessment of outcome 
measures at baseline and 1 and 3 months after the day of their index dental 
appointment (as well as assessments on the day of their index dental appointment). 

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Preliminary statistical analysis will include measures of central tendency and 
dispersion, as well as an examination of the bivariate relationships among the primary 
and secondary outcome variables (e.g., client satisfaction, blood-injury-injection 
phobia), potential moderators (e.g., distress tolerance and pain sensitivity), and 
demographic characteristics.  
 
Differences between the groups on baseline demographic, clinical and psychological 
measures will be examined using χ2 (Pearson) or Student’s t-tests, as appropriate. 
Moreover, differences on the variables listed above among completers and drop-outs 
will also be explored.  Both per protocol and intention to treat (ITT) analyses will then be 
conducted.  
 
Specific Aim 1 
 
Aim 1 will test the equivalence hypothesis (Ho: the two intervention conditions are not 
equivalent). MDAS and ADIS fear scores will be the primary outcomes to be compared 
between two intervention conditions for equivalence. The two one-sided tests (TOST) 
procedure of Schuirmann (1987) will be used to conduct the equivalence test. Linear 
mixed-effects models for repeated measures will be used to assess differences 
between intervention groups using the MDAS and ADIS fear rating as continuous 
outcome variables. Linear mixed-effects models will also investigate the treatment effect 
on dental anxiety or fear after accounting for other confounding factors. Similar analyses 
will be conducted for secondary outcome measures (pain sensitivity index, anxiety 
sensitivity index, sleep disturbance and sleep-related impairment scales, disability 
scale, distress tolerance scale, client satisfaction and blood-injury-injection phobia). 
Statistical significance will be set at p < 0.05. Multiple imputation (MI) will be used to 
handle missing follow-up data as described below.  
 
Aim 1 will also determine whether the Internet-based intervention reduces dental 
anxiety/fear as determined by self-ratings or assessor ratings at one month and three 
months post-intervention. Initially, we will assess within-group change of anxiety or fear 
scores for each condition separately using paired t-tests. Linear mixed-effects models 
will be used to estimate within-group reduction of anxiety/fear at assessments one and 
three months after the administration of the intervention adjusting for other covariates.    
 
Specific Aim 2 
Aim 2 will assess the superiority hypothesis (Ho: there are no significant differences 
between the interventions and control). MDAS and ADIS-5 fear scores will be the 
primary outcomes to be compared. Initially, we will assess the differences between the 
interventions and control using two-sample t-tests. The main analysis will be based on 
linear mixed-effects models for repeated measures (using the MDAS score and ADIS-5 
fear rating as continuous outcome variables) to assess differences between intervention 
and control groups. Linear mixed models will also investigate the treatment effect on 
dental anxiety or fear after accounting for other confounding factors. Similar analyses 
will be conducted for secondary outcome measures (e.g., client satisfaction and blood-

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injury-injection phobia). Statistical significance will be set at p < .05. MI will be used to 
handle missing follow-up data as described below.  
 
Specific Aim 3 
 
Aim 3 examines the impact of the intervention on attendance at scheduled dental 
appointments over the following 12-month period to determine whether the intervention 
affects avoidance of dental procedures. First, we will examine whether the overall 
attendance rate is changed from pre- to post-intervention using a one-sample Chi-
square test comparing the 12-month periods immediately before and immediately after 
the delivery of the intervention. The two intervention groups combined will be used for 
this analysis. We will also use a Chi-square test to compare post-intervention 
attendance rates between the two intervention groups. We expect the attendance rates 
will be similar for the two groups. Finally, we will conduct logistic regression analyses 
predicting attendance/nonattendance among intervention patients who did or did not 
demonstrate reduction in dental anxiety at 3-month follow-up. Relevant demographic 
characteristics and other potential confounding variables or moderators will be included 
in the final logistic models. 
 
Missing Data 
 
MI will be used to handle missing follow-up data when conducting ITT analysis for 
Specific Aims 1 and 2. There will be three steps in the MI procedure: 1) The missing 
follow-up data will be filled in 100 times to generate 100 complete datasets; 2) The 100 
datasets will be analyzed by analyses of covariance with follow up scores at 1-month or 
3-month as outcomes and treatment groups as the independent variable (Tr1 vs. Tr2 for 
Specific Aim 1, or Tr1 + Tr2 vs. AC for Specific Aim 2), controlling for baseline scores; 
3) The results from the 100 complete datasets will be combined for the MI inference 
(Rubin 1987). SAS PROC MI and PROC MIANALYZE will be used for multiple 
imputation analysis using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). 
 
Analysis of Secondary Objectives  
 
To determine whether primary objectives 1 and 2 are reflected in measures of other 
related constructs such as pain sensitivity, distress tolerance, anxiety sensitivity, and 
anticipated and perceived pain and anxiety, the statistical methods described above will 
be used. The moderating role of distress tolerance and pain sensitivity as expressed in 
the secondary objectives will be assessed as well. We will examine whether baseline 
levels of distress tolerance and pain sensitivity moderate the efficacy of the dental 
anxiety intervention. We will examine the moderating effect of these factors on the 
intervention and the reduction in dental anxiety at the 1-month and 3-month follow-ups. 
For moderation analyses, we will include a dummy variable for randomization arm, the 
potential moderator variable (distress tolerance or pain sensitivity), and an interaction 
term between the two (i.e. dummy variable multiplied by the mean-centered moderator 
variable). To maintain power to detect moderation, we will explore moderators 

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separately. We will also use linear-mixed effects models in which we include potential 
confounding variables, as well as main effects and interaction terms of interest.  
 
d) Withdrawal of Subjects 
 
We do not expect that there will be much in the way of withdrawal during the dental 
anxiety intervention itself, although it is not entirely out of the realm of possibility. We 
expect that the major concerns will have to do with the assessments over time, and in 
that case, concerns over withdrawal are really concerns over retention. However, we 
note a few issues below. 
 
Reasons for Withdrawal related to the Intervention 
First, patients may become highly distressed during the dental anxiety intervention. This 
is most likely to occur because of their high level of distress in anticipation of either the 
dental anxiety intervention or the dental appointment itself, and it will be most likely to 
show itself when, as part of the intervention, patients are asked to view video recordings 
of dental procedures (described earlier in this document). This level of distress is 
common, but in running a large number of patients through the study of the computer-
based version of the intervention, it never reached a level at which the patient asked to 
be withdrawn or clinical staff thought it necessary.  Although one patient stated that the 
dental anxiety intervention made her so anxious that she was going to cancel her 
following dental appointment, she did not do so, and during the debriefing interview 
thereafter, she noted that she was able to use some of what she learned in the dental 
anxiety intervention to ease herself through the actual dental procedures. Nevertheless, 
the possibility exists that some patient(s) will become so distressed by the dental 
anxiety intervention or display some other negative psychological state that they must 
be withdrawn. 
 
The second reason for withdrawal is if the patient does not attend the scheduled dental 
appointment after the dental anxiety intervention, as we consider the dental 
appointment to be an integral part of the intervention, an opportunity to practice skills 
learned in the dental anxiety intervention immediately in a “real-world” context. Note that 
this circumstance may also arise if the dental clinic staff unilaterally reschedules the 
patient’s dental appointment. 
 
The third reason for withdrawal is failure to appear for the dental anxiety intervention. 
 
The fourth reason is for failure to comply with the required assessments, either at 
baseline or at the follow-up assessments. 
 
Handling of Subject Withdrawals or Subject Discontinuation of Study Intervention 
For the first reason (patient distress during the dental anxiety intervention), if the study 
clinician judges it appropriate, he/she will stop the intervention and provide supportive 
counseling as needed.  He/she may assist the patient in rescheduling the following 
dental appointment if it appears that the patient intends to cancel or remains too 
distressed to follow through with it on that day. He/she will provide referrals for 

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individualized treatment as needed.  During this time, to the extent that clinical 
circumstances allow, he/she will attempt to ascertain whether specific portions of the 
intervention contributed to the patient’s distress (that is, to the extent possible, he/she 
will attempt to conduct the post-intervention debriefing interview or gather as much of 
that type of information as the patient will tolerate). Dr. Tellez or Dr. Dunne will be 
available by cell phone to consult as needed in this process. 
 
For the second reason (failure to attend the following dental appointment), the patient 
will be withdrawn from study consideration unless the dental appointment can be 
rescheduled within 72 hours.  We will attempt to help patients do so, because it is likely 
that they would still benefit from the dental anxiety intervention if the dental appointment 
can be rescheduled more or less immediately; research staff will interact with dental 
clinic staff to facilitate this as much as possible. 
 
For the third reason (failure to attend the dental anxiety intervention), the patient will be 
withdrawn after reasonable attempts to reschedule have failed or if there is a 
rescheduled appointment and the patient fails to appear.   
 
For the fourth reason (failure to complete assessments), the circumstances will be 
different depending on the timing of the problematic assessment. If the patient does not 
complete the pre-intervention assessments, the intervention will not be delivered, and 
thus the patient will be effectively withdrawn. The patient will be called no less than 3 
times to facilitate such completion, but a number of patients may not complete because 
of this issue.  They will be replaced so that we reach our enrollment target. If the patient 
fails to complete assessments at follow-up, no less than 3 calls will be made, but the 
patient will be considered lost to follow-up rather than withdrawn. In our recent 
randomized trial (Tellez et al., 2015), which included only a one-month follow-up, only 2 
of 46 intervention patients were lost to follow-up in this way. 
 
e) Privacy & Confidentiality 
 
 
As in any type of treatment or clinical research program, patients' privacy must be 
carefully guarded and respected. All identifying information (e.g., contact information) 
and audio recordings of interviews or video recordings of the I-CBT session will be 
stored in locked files or digitally on a HIPAA-compliant network. Remaining data will be 
stored in password-protected computer files on a HIPAA-compliant network. One file will 
contain patient names, contact information, and associated subject codes; at the end of 
the study, this file will be destroyed. All other data will reside in a file identified by 
subject codes and from which other identifying information will have been removed, so 
the link between these data and subject identifiers will have been severed.  
 
All assistants and others working on the project will be educated about the importance 
of strictly respecting patients' rights to confidentiality and will have completed training 
concerning proper practice in accordance with HIPAA regulations.  
 

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Data files will be accessible only to the investigators, study coordinator, postdoctoral 
fellow, doctoral student, and research assistants directly connected with the study. Only 
members of the research team will review the data. To help patients feel at ease, the 
study coordinator and other staff will emphasize their right to ask questions throughout 
the study and to abstain from any aspect of the research which makes them 
uncomfortable. 
 
No data will be shared with persons unassociated with the project without prior written 
release from the patient. When the results of this protocol are published, no participant 
will be identified by name. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. A Certificate of Confidentiality helps protect identifiable information and 
biological samples. The researchers with this Certificate may not disclose or use 
information, documents, or biospecimens that may identify participants in any federal, 
state, or local civil, criminal, administrative, legislative, or other action, suit, or 
proceeding, or be used as evidence, for example, if there is a court subpoena, unless a 
participant has consented for this use. Information, documents, or biospecimens 
protected by this Certificate cannot be disclosed to anyone else who is not connected 
with the research except, if there is a federal, state, or local law that requires disclosure 
(such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if a 
participant has consented to the disclosure, including medical treatment; or if it is used 
for other scientific research, as allowed by federal regulations protecting research 
subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the 
United States federal or state government agency sponsoring the project that is needed 
for auditing or program evaluation by the National Institute of Dental and Craniofacial 
Research (NIDCR) which is funding this project or for information that must be disclosed 
in order to meet the requirements of the federal Food and Drug Administration 
(FDA).  Participants should understand that a Certificate of Confidentiality does not 
prevent the voluntary release of information about themselves or their involvement in 
this research. If a participant wants their research information released to an insurer, 
medical care provider, or any other person not connected with the research, they must 
provide consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by 
federal, state, or local law of child abuse and neglect, or harm to self or others. The 
Certificate of Confidentiality will not be used to prevent disclosure for any purpose a 
participant has consented to in this informed consent document (their baseline dental 
anxiety score will be reported to the dentist prior to the scheduled dental appointment). 
 
 
9) Risks to Subjects 
 

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Risks Associated with Intervention Procedures: 
 
Internet-based dental anxiety treatment intervention: Based on our experience with the 
computer-based version of this intervention and our pilot of the online version as part of 
the R34 project, there are few significant risks.  It is certainly possible, and will 
undoubtedly be the case for a subset of the sample, that the patient could experience 
elevated anxiety while interacting with the intervention materials, as these involve 
exposure to descriptions or videos of dental procedures selected specifically because 
they induce anxiety or are avoided in real life.  In our earlier acceptability trial of the 
computer-based version, some patients did note elevations of anxiety and 
accompanying physiological symptoms, and some reported annoyance about it, but 
none asked to stop the intervention midway, and none chose to cancel their 
immediately following appointments for dental treatment. This experience was 
replicated in the randomized controlled trial and the piloting that occurred as part of the 
R34 grant. 
 
Active Control Condition: This comparison condition will have patients pursue their 
scheduled dental appointment as usual, with the exception that their score on their 
most recent administration of the MDAS, the measure of dental anxiety, would be 
shared with the dental care provider (also the case in the intervention conditions). 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. We cannot foresee any 
significant risks associated with these procedures. 
 
Recording: Some patients may feel uncomfortable about the treatment sessions being 
recorded for the assessment of treatment fidelity, but this will be a required procedure. 
Treatment fidelity ratings as well as informal observations of session video-recordings 
by the study coordinator will be used for feedback to dental assistants undergoing 
training. Debriefing interviews, which will be audio-recorded, will provide additional 
important information about modifications that may need to be made to the dental 
anxiety intervention in advance of further research on the treatment of dental anxiety. 
  
Risks Associated with Assessment Procedures: 
 
Self Report Measures and Assessor Ratings: No risks are seen associated with these 
assessment procedures other than discomfort associated with thinking about one’s 
dental anxiety as well as the recording of assessor interviews involving the disclosure of 
personal information. Recording will be necessary for the measurement of inter-rater 
agreement on interview measures. 
 
Protection Against Risk: 
 
 
 
 
 
 
 
 
 
 
 
1. 
Careful screening to identify patients whose risk for potential adverse outcomes 
is elevated were they to participate in the proposed research. Such patients will be 
excluded from the study. As an example, an actively suicidal patient would be excluded 
from study participation and appropriate clinical treatment provided.  
 

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2. 
Clinical staff will be trained to cope with any anxiety experienced by specific 
patients during treatment sessions. Here we refer to psychology staff who have 
experience in the treatment of anxious patients, at least one of whom will be on site (or 
available by cell phone) at all times to provide support for any patient who is unusually 
troubled by the experiences of the intervention. As a further safeguard, we have added 
a section to both the didactic portion of the training for therapy aides (both psychology 
staff and dental assistants) and the accompanying manual on the identification of and 
intervention with extreme anxiety reactions that may occur as a result of exposure to the 
intervention materials. As noted above, we see this risk as quite small, but not 
impossible. 
 
3. 
Continuing contact with patients during the follow-up period. Patients will have 
contact with the same assessors at follow-up assessments as they did at baseline 
whenever possible. Patients will be encouraged to make contact with project staff 
between contacts if their dental anxiety or any reaction to the intervention causes undue 
distress. In that case, a discussion will be engaged about whether or not the patient 
should be withdrawn from the follow-up phase of the study and given appropriate 
clinical care. That care may take any of a variety of forms and may be offered through 
the Psychological Services Center of Temple University or through appropriate referral, 
depending on resources and the type of treatment desired by the patient. 
 
4. 
As in any type of treatment or clinical research program, patients' confidentiality 
must be carefully guarded and respected. All data with identifying information will be 
stored in locked files or password-protected computer files. Data being analyzed will be 
identified by subject codes, and identifying information will be removed. All assistants 
and others working on the project will be educated about the importance of strictly 
respecting patients' rights to confidentiality and will have completed training concerning 
proper practice in accordance with HIPAA regulations.  
 
5. 
In addition to the investigators’ responsibility for oversight, study oversight will be 
under the direction of the NIDCR Medical Monitor. The investigators will submit a report 
every 6 months to the NIDCR Medical Monitor for review. This report will include data 
regarding enrollment and retention, unanticipated problems and protocol deviations, 
outcome measures, quality management findings and other relevant parameters.  
The IRB and the designated program person at NIDCR will be notified in writing by Dr. 
Tellez or Dr. Dunne if a serious adverse event occurs.  A serious adverse event is 
defined as follows: death, life-threatening adverse event, inpatient hospitalization or 
prolongation of existing hospitalization, persistent or significant disability/incapacity, 
congenital anomaly/birth defect, and medically significant event.  Risks of participation 
will be continuously monitored and appropriate measures implemented in cases of 
unforeseen adverse events.  These events will be reported whether or not they appear 
to be related to study procedures. 
 
All protocol violations will be discussed in detail; if appropriate, the IRB will be consulted 
and corrective actions devised. All modifications to the protocol will be submitted for IRB 

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approval.  Summaries of all relevant discussions will be promptly disseminated to study 
personnel via e-mail and retraining procedures implemented as needed.  
 
10) 
Potential Benefits to Subjects 
An earlier iteration of the dental anxiety intervention demonstrated efficacy in the 
treatment of dental anxiety in the same population of patients from which the current 
sample will be drawn.  Therefore, it is possible that a portion of the patients in this study 
will realize a reduction in their own dental anxiety, although this cannot be assured for 
any specific patient. Patients will receive a thorough assessment of their dental anxiety, 
and the intervention includes substantial educational material about dental anxiety, 
which should be to their benefit, regardless of anxiety reduction. Patients will be offered 
referrals for further treatment of dental anxiety, through the Temple University 
Psychological Services Center or elsewhere, should they be interested in pursuing this. 
 
11) 
Costs to Subjects 
Dental anxiety intervention is provided without charge.  The investigators are not 
involved in the determination of cost of actual dental procedures, but no additional 
dental procedures will be conducted in the course of this research. 
 
12) 
Informed Consent  
 
The protocol will follow INVESTIGATOR GUIDANCE: Informed Consent (HRP-
802) to obtain informed consent from participants. The proposed sequence is 
described as part of the narrative to follow. Although we have been thorough in 
delineating possible risks to participants, our experience with the prior computer-
based version of the dental anxiety intervention suggests that this is truly a 
minimal risk study. However, we understand that that determination is ultimately 
one for the IRB rather than the investigators. 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
patients during the screening contact (Time 0) and  electronic informed consent will be 
obtained at the first in-person visit (Time 2). Copies of the signed primary consent form 
will be emailed  to patients for their records at the first Clinic Visit. The rights and 
welfare of the patients will be protected by emphasizing to them that the quality of their 
clinical care will not be adversely affected if they decline to participate in this study. 
Patients may withdraw consent at any time over the course of the study. 
The consent process will be documented in the clinical or research record.   
Participants in this study will be patients who have scheduled appointments for non-
emergent dental procedures through the Faculty Practice Clinic at TUKSoD (and the 
Graduate Clinics of TUKSoD, if necessary). All such persons will be contacted by 

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telephone and asked if they would be willing to be screened for dental anxiety and, if so, 
if they would be interested in the possibility of participating in a study of the treatment of 
dental anxiety. If the potential participant gives a positive response, the 5-item dental 
anxiety screening measure, two additional screening questions (age, impairment as a 
result of dental anxiety), and a medical screening interview will be administered (see 
Recruitment Methods section for a more detailed presentation of specific procedures). If 
the participant meets criteria and continues to express interest in the study, extensive 
information about the study and the risks and possible benefits of study participation will 
be provided (the caller will provide a full summary of the primary study consent form 
over the telephone with the potential participant and verbal consent for full study 
participation will be obtained). If patients remain interested in participation, they will be 
scheduled for a second (“baseline”) interview and questionnaire administration.  
 
At the Clinic Visit on the day of the dental anxiety intervention (or control session), the 
primary study consent form will be reviewed with the patient and remaining questions 
answered. A copy of this signed consent form will be provided to the patient via email, 
but a physical copy can also be provided upon request. As part of the overall consent 
procedure, patients will be informed of the nature of the investigation, the types of 
assessments and treatments involved, the recording of debriefing/assessment 
interviews and intervention sessions, alternative treatments, and the potential risks 
involved in participation. In addition, an explanation of how information related to their 
case will be handled will be presented. The IRB will have approved the protocol and 
consent form prior to implementation. 
 
13) 
Vulnerable Populations 
 
Not applicable. Individuals who are vulnerable to coercion or undue influence will not be 
included in the human subjects activities described herein.  
 
14) 
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