vol. XX • issue X • suppl no.

X JDR Clinical Research Supplement

Clinical Trials

Computerized Tool to Manage Dental

Anxiety: A Randomized Clinical Trial
M. Tellez1*, C.M. Potter2, D.G. Kinner2, D. Jensen2, E. Waldron2, R.G. Heimberg2, S. Myers Virtue1,
H. Zhao3, and A.I. Ismail1

Abstract: Anxiety regarding dental
and physical health is a common and
potentially distressing problem, for both
patients and health care providers.
Anxiety has been identified as a bar-
rier to regular dental visits and as an
important target for enhancement of
oral health–related quality of life. The
study aimed to develop and evaluate
a computerized cognitive-behavioral
therapy dental anxiety intervention
that could be easily implemented in
dental health care settings. A cognitive-
behavioral protocol based on psycho-
education, exposure to feared dental
procedures, and cognitive restructur-
ing was developed. A randomized con-
trolled trial was conducted (N = 151)
to test its efficacy. Consenting adult
dental patients who met inclusion cri-
teria (e.g., high dental anxiety) were
randomized to 1 of 2 groups: imme-
diate treatment (n = 74) or a wait-list
control (n = 77). Analyses of covari-
ance based on intention-to-treat anal-
yses were used to compare the 2 groups
on dental anxiety, fear, avoidance,
and overall severity of dental phobia.
Baseline scores on these outcomes were
entered into the analyses as covariates.
Groups were equivalent at baseline but
differed at 1-mo follow-up. Both groups
showed improvement in outcomes,
but analyses of covariance demon-
strated significant differences in den-
tal anxiety, fear, avoidance, and over-
all severity of dental phobia in favor
of immediate treatment at the follow-
up assessment. Of the patients who met
diagnostic criteria for phobia at base-
line, fewer patients in the immediate
treatment group continued to meet cri-
teria for dental phobia at follow-up as
compared with the wait-list group. A
new computer-based tool seems to be
efficacious in reducing dental anxi-
ety and fear/avoidance of dental pro-
cedures. Examination of its effective-
ness when administered in dental
offices under less controlled condi-
tions is warranted (ClinicalTrials.gov
NCT02081365).
Key Words: dental phobia, dental fear,
cognitive behavioral therapy, dental
attendance, efficacy, psychoeducation.
Introduction
Dental anxiety and specific phobia
of dental procedures are prevalent
conditions that can result in substantial
distress and oral health impairment,
affecting 10% to 20% of adults in various
US population groups (Locker et al.
1999; Sohn and Ismail 2005; Tellez et al.
2015). Few computer-aided interventions
tested in randomized clinical trials have
targeted dental anxiety. Although 1
computer-based treatment for dental
injection fear has been evaluated (the
CARL Program; Coldwell et al. 1998;
Heaton et al. 2013), the current study
tests the efficacy of a computerized
treatment for a broader range of dental
concerns.
Cognitive-behavioral interventions have
garnered strong support in the treatment
of dental anxiety. A meta-analysis of 38
studies focusing on cognitive-behavioral
therapy (CBT; Kvale et al. 2004) provides
support for its efficacy in reducing
dental anxiety among adults, even when
administered in a limited number of brief
sessions (de Jongh et al. 1995; Thom
et al. 2000; Jöhren et al. 2007; Haukebø
et al. 2008; Wannemueller et al. 2011).
A recent review that critically appraised
22 randomized treatment trials aimed at
reducing dental anxiety and avoidance in
adults (Gordon et al. 2013) also
provided support for brief CBT
interventions. Furthermore, a recent
study demonstrated that a brief
cognitive-behavioral intervention
performed by practicing dentists may
help fearful patients overcome their
fear and attend dental treatments
more regularly (Spindler et al. 2015).
However, this intervention would
require dentists to receive training in
psychotherapy, be comfortable with
performing the intervention, and have
the necessary tools to distinguish
patients who may need more intensive

DOI: 10.1177/0022034515598134. 1Maurice H. Kornberg School of Dentistry, Temple University, Philadelphia, PA, USA; 2Adult Anxiety Clinic of Temple, Department of
Psychology, Temple University, Philadelphia, PA, USA; and 3School of Medicine, Temple University, Philadelphia, PA, USA; *corresponding author, marisol@temple.edu
© International & American Associations for Dental Research

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© International & American Associations for Dental Research

 JDR Clinical Research Supplement
treatment elsewhere. Self-administered
treatments have also shown promise
(Getka and Glass 1992), and the utility
of computerized or online interventions
should be investigated.
This study aimed to develop and
evaluate a computerized CBT (C-CBT)
dental anxiety intervention that could be
easily implemented in dental health care
settings.
Materials and Methods
Design
This was a single-center parallel
study with randomization to either an
immediate treatment (IT) group or a
wait-list (WL) control group (allocation
ratio:1:1). IT participants received C-CBT
immediately preceding their scheduled
dental appointments. WL participants
attended their scheduled dental
appointments without receiving C-CBT
and were offered the same intervention
following all assessments. Data from the
later treatment of WL patients are not
included in the present analyses. No
changes were made to outcomes after
commencement of the trial.
Sample Selection
The main hypothesis to be tested (H0:
There are no significant differences
between IT and WL) was subjected to
power analysis. Assuming an average
change in Modified Dental Anxiety Scale
(MDAS; Humphris et al. 1995) mean
scores of 5 ± 10 in the IT group and no
change in the WL group, with a power
of 0.80, an α level of 0.05, and a 2-tailed
test, we determined that 150 participants
should be recruited. Recruitment was
carried out through the Faculty Practice
Clinic at the Temple University Kornberg
School of Dentistry (TUKSoD) in 2014. All
new patients were identified through the
clinic’s electronic scheduling software and
invited to participate before their dental
appointments if they met screening criteria
on the MDAS. There were no restrictions
on enrollment in terms of sex, economic
status, or ethnic group.
To be included, patients had to be
between 18 and 70 y of age, be fluent
in spoken and written English, have
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scheduled a dental treatment appointment
at the TUKSoD Faculty Practice Clinic, be
willing and able to give informed written
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 semistructured
diagnostic interview. Participants received
a $25 money order for completing the
baseline questionnaires and telephone
interview and, if randomized to IT, for
coming to their dental appointment
1.5 h early to complete C-CBT.
Furthermore, all participants received an
additional $25 payment for completing
their 1-mo follow-up questionnaires. The
trial was stopped when recruitment targets
were reached. The study was approved
by the Institutional Review Board at
Temple University (protocol 13928). All
patients provided informed consent. The
trial is registered at ClinicalTrials.gov
(NCT02081365).
Procedure
Participation in the study involved
completing 1) self-report questionnaires
online (or, for individuals without
Internet access, by telephone) and
2) a telephone diagnostic interview.
The research assistants at the clinic
administered the randomization of
participants (computer generated) and
distribution of appointments. The file
was secured and restricted to the time of
randomization. Randomization was done
after baseline assessments for two-thirds
of the sample, while for one-third, it was
done before the assessments.
For practical and ethical reasons related
to the fact that participants were paying
for the dental treatment themselves and
the immediacy of treatment to which they
were allocated, we could not blind them
to the outcome of the randomization.
After randomization, each participant
was instructed to complete the self-report
assessments and the diagnostic interview
before coming in for their dental
appointment. IT participants were asked
to come in 1.5 h before their dental
appointment to complete C-CBT, whereas
those in the WL group simply attended
their dental appointment as normally
© International & American Associations for Dental Research
Month XXXX
scheduled. One month after the dental
appointment, participants were contacted
by phone and asked to complete
follow-up assessments. If a participant
did not respond to study staff’s initial
contact attempt for the follow-up
assessment, research assistants continued
to call that participant weekly for 1 mo.
Participants who never responded to
these requests for follow-up assessment
were considered lost to follow-up.
Intervention
C-CBT consisted of a single-session 1-h
computerized intervention that assisted the
participant in building skills for managing
his or her dental anxiety. Participants
completed C-CBT in a research office near
the TUKSoD Faculty Practice Clinic on a
desktop computer with headphones. The
intervention was delivered with the aid
of a research assistant who was available
to answer any questions and to assist
participants with any aspect of C-CBT that
they found difficult.
C-CBT began with a psychoeducation
module, which provided participants
with basic education about the nature
of dental anxiety. Next, patients were
guided through a brief motivational
interviewing exercise that helped them
consider the benefits and drawbacks
of working on their dental anxiety.
Thereafter, patients were guided through
the exposure exercises, which included
opportunities to practice coping with
their dental anxiety. For the exposure
exercises, patients were first asked
to select their 3 most feared dental
procedures from a list of 6 (drilling and
having a cavity filled, cleaning, anesthetic
injection, root canal, oral X-ray, and tooth
extraction) and rank them from least to
most anxiety provoking. Patients then
watched video recordings of their top-3
feared procedures, starting with the least
anxiety provoking and working up to
the most. For each selected procedure, 3
videos were presented:
1) The first video depicted a dentist
and/or hygienist conducting the
procedure with a patient and
provided a basic explanation of the
procedure. Animations of aspects of
 vol. XX • issue X • suppl no. X
the procedure that occur within the
mouth were included, as were close-
ups of the dental tools employed.
2) The second video presented similar
visuals of the dental procedure but
was more focused on the patient’s
emotional experience during the pro-
cedure. The voiceover provided basic
training in the nature and use of cog-
nitive coping skills for dental anxiety.
3) The third video was filmed from the
perspective of the patient in the den-
tal chair and provided more intensive
exposure to the feared dental proce-
dure. Furthermore, the voiceover was
a “dialogue” between the patient from
the first 2 videos, who demonstrated
how to effectively cope with anxious
thoughts, and the participant, who
was led through the steps to develop
coping thoughts for his or her own
dental anxiety.
The intervention closed with a brief
module providing additional motivational
enhancement for attending future dental
appointments. Upon completing the
intervention, participants attended their
scheduled dental appointments and were
encouraged to use the skills that they
learned from C-CBT to cope with any
anxiety that they experienced during that
appointment.
Measures
Primary Measure: Dental Anxiety
Dental anxiety was measured with
the MDAS, a 5-item self-report measure
that assesses fear of dental procedures,
including drilling, scaling and polishing
(i.e., cleaning), and local anesthetic
injections. Sample items include “If
you went to your dentist for treatment
tomorrow, how would you feel?” and
“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 MDAS has
demonstrated good internal consistency
(α = 0.89) and test-retest reliability (r =
0.82, interval unspecified; Humphris
et al. 1995). A total MDAS score ≥19 has
been used as an indicator of high dental
anxiety (Humphris et al. 1995; King &
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Humphris 2010); however, concerns
have been raised about this cutoff, as it
could exclude individuals who are very
or extremely anxious about only 1 of 2
types of dental procedures (Dailey et al.
2002). Therefore, in the present study, we
considered patients who scored ≥19 on
the MDAS at baseline or endorsed at least
2 MDAS items ≥4 to have high dental
anxiety. This method has demonstrated
superior sensitivity and specificity
compared with the conventional scoring
procedure (Schulman et al. 2014).
Secondary Measures: Semistructured
Diagnostic Interview
The Anxiety Disorders Interview
Schedule (ADIS-IV; Brown et al. 1994)
is a semistructured diagnostic interview
designed to assess criteria per the fourth
edition of the Diagnostic and Statistical
Manual of Mental Disorders (American
Psychiatric Association 1994) for current
anxiety, depressive, somatoform, and
substance use disorders. The ADIS-IV has
demonstrated good to excellent interrater
reliability for the diagnosis of all assessed
disorders (k = 0.56 to 0.81; Brown et al.
2001), with the exception of dysthymic
disorder (k = 0.31). All diagnosticians
were advanced doctoral students or
research assistants who were trained
to strict reliability standards established
by Brown et al. (2001). For the present
investigation, only the specific phobia
module of the ADIS-IV was administered
to assess the presence and severity of a
current diagnosis of dental phobia. Details
regarding the assessment and computation
of each variable are provided below.
Dental Phobia
Various aspects of dental phobia were
assessed using the specific phobia
module of the ADIS-IV. Interviewers
assessed participants’ anxiety and
avoidance of dental procedures on scales
that ranged from 0 (none) to 8 (very
severe). They also rated patients’ overall
distress and impairment due to their
dental phobia symptoms and assigned a
clinician’s severity rating that also ranged
from 0 (none) to 8 (very severe); a rating
≥4 indicated that the participant met
criteria for diagnosis of dental phobia.
© International & American Associations for Dental Research
JDR Clinical Research Supplement
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire
(CSQ-8; Larsen et al. 1979) is an 8-item
self-report questionnaire designed to
assess client/patient satisfaction in
health and human services. Each item is
rated on a 4-point scale. Individual item
scores are summed, resulting in a total
score ranging from 8 to 32, with higher
scores indicating higher satisfaction. The
CSQ-8 has demonstrated high internal
consistency in multiple clinical samples in
mental health settings (α = 0.92 to 0.93,
Larsen et al. 1979; split-half reliability
r = 0.82, Nguyen et al. 1983). The CSQ-8
was administered immediately after
patients completed C-CBT to assess their
satisfaction with the program.
Statistical Analyses
Differences between the groups on
baseline sociodemographic, clinical, and
psychological measures were examined
using χ2 (Pearson) or Student’s t tests,
as appropriate (see Table 1). Moreover,
differences on the variables listed above
among completers and dropouts were
also explored, but no differences were
found. Both per-protocol and intention-
to-treat (ITT) analyses were then
conducted, but only ITT analyses are
reported in the Results section.
To address our aim, analysis of
covariance (ANCOVA) was used to
compare the 2 groups on primary and
secondary outcome measures. Baseline
scores on the outcome of interest were
entered into the analyses as covariates,
as was sex in the analysis of the MDAS
scores, as sex differed between IT and
WL groups at baseline (P = 0.032; Table
1). Data were analyzed with SPSS 22.0
(IBM Corporation, Armonk, NY, USA).
Multiple Imputation
Multiple imputation (MI) was used to
handle missing follow-up data. There
were 3 steps in the multiple-imputation
procedure:
1) The missing follow-up data were
filled in 100 times to generate 100
complete data sets.
2) The 100 data sets were analyzed by
ANCOVAs with follow-up scores as
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 JDR Clinical Research Supplement Month XXXX

Table 1.
Baseline Differences by Condition

Immediate Treatment Wait-list Control Total P Valuea

Patient meets criteria for phobia 0.191
 Yes 46 (62.2) 50 (64.9) 96 (63.6)
 No 6 (8.1) 13 (16.9) 19 (12.6)
 Missing 22 (29.7) 14 (18.2) 36 (23.8)
Race 0.533
 White 20 (27.0) 18 (23.4) 38 (25.2)
  Black or African American 34 (45.9) 44 (57.1) 78 (51.7)
 Asian 2 (2.7) 2 (2.6) 4 (2.6)
 Other 6 (8.1) 3 (3.9) 9 (6.0)
 Missing 12 (16.2) 10 (13.0) 22 (14.6)
Ethnicity 0.891
  Hispanic or Latino 5 (6.8) 5 (6.5) 10 (6.6)
  Not Hispanic or Latino 53 (71.6) 58 (75.3) 111 (73.5)
 Missing 16 (21.6) 14 (18.2) 30 (19.9)
Sex 0.032
 Male 22 (29.7) 36 (46.8) 58 (38.4)
 Female 52 (70.3) 41 (53.2) 93 (61.6)
Age, y, mean ± SD 44.7 ± 12.8 44.6 ± 13.6 44.7 ± 13.1 0.936

Values are presented as n (%) unless noted otherwise.

a
P from chi-square / Fisher’s exact test / t test. P values excluded missing data.

outcomes and with the treatment
group as the independent variable
(IT vs WL), controlling for baseline
scores.
3) The results from the 100 complete
data sets were combined for the
multiple-imputation inference (Rubin
1987).
SAS PROC MI and PROC MIANALYZE
were used for multiple-imputation
analysis using SAS 9.3 (SAS Institute Inc.,
Cary, NC, USA).
Results
Demographics
Of 961 new patients who received
recruitment calls, 354 expressed interest
and were assessed for eligibility. A total
of 151 patients were eligible, consented
to participate, and were randomized to
IT (n = 74) or WL (n = 77; Fig.). Eighteen
WL participants and 28 in the IT group
did not receive the allocated intervention.
Of the remaining 105 participants who
completed the baseline assessment, 5
WL and 2 IT participants were lost to
follow-up. The total sample comprised
151 adults seeking dental care at the
TUKSoD Faculty Practice Clinic (female,
61.6%; mean age, 44.7 ± 13.1 y; range, 18
to 70 y). The racial/ethnic composition of
the sample was generally consistent with
that of north Philadelphia (U.S. Census
Bureau 2010): approximately 51.7% of
participants identified as black, 25.2% as
white/Caucasian, 2.6% as Asian or Pacific
Islander, and 6.0% as other. As noted
above, no significant differences between
groups on baseline demographic or
clinical measures were found, except for
sex (see Table 1).
Efficacy of C-CBT
Groups were equivalent at baseline but
differed at 1-mo follow-up. Both groups
showed improvement in outcomes,
but ANCOVAs demonstrated significant
differences in dental anxiety, fear,
avoidance, and overall severity of dental
phobia in favor of IT at the follow-up
assessment.
Primary Measure
MDAS scores decreased from baseline
(19.5 ± 0.34) to 1-mo follow-up (15.4
± 0.74) for the IT group (see Table 2).
An ANCOVA with the ITT sample (N =
151) confirmed that the IT group had
MDAS scores that were 2.2 points (95%
confidence interval [95% CI]: 0.74, 3.55)
lower than those of the WL group (P =
0.019) after controlling for the effect of
baseline MDAS scores and sex.
Secondary Measures
ADIS-IV ratings of dental fear (baseline:
5.6 ± 0.17, follow-up: 3.8 ± 0.26),
dental avoidance (baseline: 4.6 ± 0.31,
follow-up: 1.3 ± 0.31), and overall
severity of dental phobia symptoms
(baseline: 5.3 ± 0.19, follow-up: 3.4 ±
0.27) decreased from baseline to 1-mo
follow-up for the IT group (see Table 2).

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© International & American Associations for Dental Research

 vol. XX • issue X • suppl no. X JDR Clinical Research Supplement

ANCOVAs with the ITT sample Figure.

(N = 115) revealed significant between- CONSORT flowchart.
group differences on the ADIS-IV—
dental fear, 1.23 points (95% CI: 0.61, Received a recruitment call (n = 961)
1.85), P = 0.0001; dental avoidance,
0.82 points (95% CI: 0.01, 1.64), P =
0.047; and overall severity of dental Not assessed for eligibility (n = 607)
phobia symptoms, 0.98 points (95% Could not be reached (n = 459)
Were not interested (n = 148)
CI: 0.39, 1.57), P = 0.0012—all favoring
the IT group after controlling for the
corresponding baseline scores. Of
Assessed for eligibility (n = 354)
patients meeting criteria for phobia at
baseline (n = 83), fewer IT patients
(51.4%) than WL patients (74.4%) met
criteria for dental phobia at follow-up Excluded (n = 203)
Did not meet inclusion criteria (n = 170)
(χ2 = 4.319, P = 0.038). No harms were Refused to participate (n = 33)
noted.
Client Satisfaction with C-CBT Randomized (n = 151)

The mean CSQ score was 26.4 ±

4.4. Almost 83% of patients were very
satisfied with C-CBT. Allocated to waitlist (n = 77) Allocated to immediate treatment (n = 74)
Received allocated intervention Received allocated intervention
(n = 59)* (n = 46)*
Discussion
Allocation

Did not receive allocated Did not receive allocated

intervention (n = 18) intervention (n = 28)
o Did not complete pre- o Did not complete pre-treatment
This study examined the effect of treatment phone phone interview (n = 9)
interview (n = 6)
a brief computerized dental anxiety o Missed dental
o Did not come to dental
appointment early enough to
intervention on patients seeking dental appointment (n = 12) complete intervention (n = 7)
care at a university setting. Compared o Missed dental
appointment (n = 11)
with a WL group, the IT group showed
a significant reduction in dental anxiety,
fear, avoidance, and the presence
of dental phobia as measured by a
reduction from baseline to follow-up on
Follow up

*Received allocated intervention (n = 59) *Received allocated intervention (n = 46)

the MDAS and ADIS-IV.
The use of computer-based therapy
reduces the reliance on in-person
clinician time (Marks et al. 2007), and
it may be as effective as face-to-face
psychotherapy for anxiety disorder
sufferers (Hedman et al. 2012), speeding
access to care. Many individuals
with anxiety disorders do not seek
professional help (Bijl et al. 1998). When
they do, they are commonly put on
long waiting lists (Lovell and Richards
2000), and the treatment that they
eventually receive is often not evidence
based (Andrews et al. 2004). Much less
is known about the efficacy of these
interventions in dental settings. It is
therefore important to develop evidence-
based help that patients can access
easily and that requires little time from a
therapist (Hirai and Clum 2006).
Lost to follow up (n = 5)
Received follow up (n = 54)
The current results should be
interpreted with some caution. Only
dental treatment–seeking patients who
initiated contact with the TUKSoD
dental clinics were recruited into the
study, thereby excluding individuals
whose anxiety may be present at higher
levels and thus prevent them from
accessing dental care. There was also
considerable attrition from baseline
assessment to the day of administration
of the dental anxiety protocol. Also,
in the current study, assistance from
psychology personnel trained in CBT was
provided at some points in the delivery
of the intervention. To disseminate the
Lost to follow up (n = 2)
Received follow up (n = 44)
intervention in a sustainable way, it is
critical that dental personnel are trained
in CBT so that they can provide this
support to the patients in a regular dental
setting, in which highly trained CBT
therapists are generally not available.
Last, in addition to reductions in dental
anxiety, increased attendance at future
dental appointments is also an ultimate
goal. No analyses were conducted
to evaluate this and other oral health
outcomes in the current study, as the
follow-up period was too brief; clearly,
further research is needed. In sum,
a new computer-based tool seems
to be efficacious in reducing fear of

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© International & American Associations for Dental Research

 JDR Clinical Research Supplement
Table 2.
Baseline and Follow-up Scores on Primary and Secondary Measures
Immediate Treatment
Baseline
n Mean ± SE
MDAS 74 19.5 ± 0.34
ADISb
 Fear 52 5.6 ± 0.17
 Avoidance 52 4.6 ± 0.31
 CSR 52 5.3 ± 0.19
ADIS, Anxiety Disorders Interview Schedule; CSR, clinician’s severity rating; MDAS, Modified Dental Anxiety Scale.
a
P values from analysis-of-covariance models from intention-to-treat analysis.
b
Rating, 0 to 8.
dental procedures. Examination of its
effectiveness when administered in dental
offices under less controlled conditions
is warranted. It will also be important
to determine which patients derive
sufficient benefit and which require
more intense treatment; this protocol
might be considered as the first level of
intervention in a stepped model of care.
Author Contributions
M. Tellez, R.G. Heimberg, contributed
to conception, design, data acquisition,
analysis, and interpretation, drafted
and critically revised the manuscript;
C.M. Potter, contributed to design, data
acquisition, analysis, and interpretation,
drafted and critically revised the
manuscript; D.G. Kinner, D. Jensen,
E. Waldron, S. Myers Virtue, H. Zhao,
contributed to design, data analysis,
and interpretation, drafted and critically
revised the manuscript; A.I. Ismail,
contributed to conception, design, and
data interpretation, drafted and critically
revised the manuscript. All authors
gave final approval and agree to be
accountable for all aspects of the work.
Acknowledgments
We thank Dr. Steve Ondersma for his
contribution to the programming of the
dental anxiety management intervention
and the dental and psychology students
who participated as actors in the videos
of the anxiety management program. This
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Follow-up Baseline
n Mean ± SE n Mean ± SE
74 15.4 ± 0.74 77
52 3.8 ± 0.26 63
52 1.3 ± 0.31 63
52 3.4 ± 0.27 63
study was funded by a grant from the
Pennsylvania Department of Health. The
authors declare no potential conflicts of
interest with respect to the authorship
and/or publication of this article.
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