Skip to content

Clinical Management of Anxiety and Access to Health Care

Clinical Management of Anxiety and Access to Health Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02081365
Enrollment
151
Registered
2014-03-07
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Brief summary

Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that could be easily implemented in dental healthcare settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).

Detailed description

Analyses of covariance (ANCOVAs) based on intention to treat analyses were used to compare the two groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates.

Interventions

BEHAVIORALComputerized Dental Anxiety Treatment

The Computerized Dental Anxiety Treatment Program consists of treatment modules that are be delivered through a computer. The modules use Cognitive Behavioral Therapy (CBT) to assist the participant in preparing a personal plan for managing his/her dental anxiety. The program incorporates a range of CBT techniques, including cognitive restructuring, exposure, and motivational interviewing.

Sponsors

Pennsylvania Department of Health
CollaboratorOTHER_GOV
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* high dental anxiety * fluent in spoken and written English

Exclusion criteria

* unable to provide written, informed consent

Design outcomes

Primary

MeasureTime frameDescription
Change in Modified Dental Anxiety ScaleChange from one week before dentist appointment to 1 month after dentist appointmentThe Modified Dental Anxiety Scale a five-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 five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored \> 19 on the MDAS at baseline or endorsed at least two MDAS items \> 4 to have high dental anxiety.

Secondary

MeasureTime frameDescription
Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVChange from one week before dental appointment to one-month after dental appointmentThe Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.
Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVChange from one week before appointment to one month after appointmentThe Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.
Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVChange from one week before appointment to one month after appointmentThe Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.

Countries

United States

Participant flow

Participants by arm

ArmCount
Immediate Treatment
Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT). The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments.
74
Waiting List Control
Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments.
77
Total151

Baseline characteristics

CharacteristicTotalWaiting List ControlImmediate Treatment
ADIS Specific Phobia Avoidance Rating4.2 units on a scale
STANDARD_DEVIATION 2.4
3.9 units on a scale
STANDARD_DEVIATION 2.5
4.6 units on a scale
STANDARD_DEVIATION 2.2
ADIS Specific Phobia Clinical Severity Rating5.0 units on a scale
STANDARD_DEVIATION 1.5
4.8 units on a scale
STANDARD_DEVIATION 1.6
5.3 units on a scale
STANDARD_DEVIATION 1.4
ADIS Specific Phobia Fear Rating5.4 units on a scale
STANDARD_DEVIATION 1.3
5.2 units on a scale
STANDARD_DEVIATION 1.4
5.6 units on a scale
STANDARD_DEVIATION 1.3
Age, Continuous44.7 years
STANDARD_DEVIATION 13.1
44.6 years
STANDARD_DEVIATION 13.6
44.7 years
STANDARD_DEVIATION 12.8
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants5 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
111 Participants58 Participants53 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
30 Participants14 Participants16 Participants
Gender
Female
93 Participants41 Participants52 Participants
Gender
Male
58 Participants36 Participants22 Participants
MDAS Baseline Score19.5 units on a scale
STANDARD_DEVIATION 2.8
19.6 units on a scale
STANDARD_DEVIATION 2.6
19.5 units on a scale
STANDARD_DEVIATION 2.9
Race/Ethnicity, Customized
Asian
4 participants2 participants2 participants
Race/Ethnicity, Customized
Black or African American
78 participants44 participants34 participants
Race/Ethnicity, Customized
Not reported/missing
22 participants10 participants12 participants
Race/Ethnicity, Customized
Other
9 participants3 participants6 participants
Race/Ethnicity, Customized
White
38 participants18 participants20 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 740 / 77
serious
Total, serious adverse events
0 / 740 / 77

Outcome results

Primary

Change in Modified Dental Anxiety Scale

The Modified Dental Anxiety Scale a five-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 five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored \> 19 on the MDAS at baseline or endorsed at least two MDAS items \> 4 to have high dental anxiety.

Time frame: Change from one week before dentist appointment to 1 month after dentist appointment

ArmMeasureGroupValue (MEAN)Dispersion
Immediate TreatmentChange in Modified Dental Anxiety ScaleBaseline19.5 units on a scaleStandard Error 0.34
Immediate TreatmentChange in Modified Dental Anxiety ScaleOne month follow up15.4 units on a scaleStandard Error 0.74
Waiting List ControlChange in Modified Dental Anxiety ScaleBaseline19.6 units on a scaleStandard Error 0.3
Waiting List ControlChange in Modified Dental Anxiety ScaleOne month follow up17.6 units on a scaleStandard Error 0.63
Comparison: Comparison of two groups at 1 month follow up with baseline value as the covariatep-value: <0.0595% CI: [0.74, 3.55]ANCOVA
Secondary

Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV

The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.

Time frame: Change from one week before appointment to one month after appointment

ArmMeasureGroupValue (MEAN)Dispersion
Immediate TreatmentChange in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline4.6 units on a scaleStandard Error 0.31
Immediate TreatmentChange in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up1.3 units on a scaleStandard Error 0.31
Waiting List ControlChange in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline3.9 units on a scaleStandard Error 0.32
Waiting List ControlChange in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up1.0 units on a scaleStandard Error 0.29
Comparison: Comparison of two groups at 1 month follow up with baseline value as the covariatep-value: <0.0595% CI: [0.01, 1.64]ANCOVA
Secondary

Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV

The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.

Time frame: Change from one week before dental appointment to one-month after dental appointment

ArmMeasureGroupValue (MEAN)Dispersion
Immediate TreatmentChange in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline5.3 units on a scaleStandard Error 0.19
Immediate TreatmentChange in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up3.4 units on a scaleStandard Error 0.27
Waiting List ControlChange in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline4.8 units on a scaleStandard Error 0.2
Waiting List ControlChange in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up4.0 units on a scaleStandard Error 0.23
Comparison: Comparison of two groups at 1 month follow up with baseline value as the covariatep-value: <0.0595% CI: [0.39, 1.57]ANCOVA
Secondary

Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV

The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. 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. 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 (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR \> 4 indicated that the participant met criteria for diagnosis of dental phobia.

Time frame: Change from one week before appointment to one month after appointment

ArmMeasureGroupValue (MEAN)Dispersion
Immediate TreatmentChange in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline5.6 units on a scaleStandard Error 0.17
Immediate TreatmentChange in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up3.8 units on a scaleStandard Error 0.26
Waiting List ControlChange in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVBaseline5.2 units on a scaleStandard Error 0.17
Waiting List ControlChange in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IVOne month follow up4.8 units on a scaleStandard Error 0.23
Comparison: Comparison of two groups at 1 month follow up with baseline value as the covariatep-value: <0.0595% CI: [0.61, 1.85]ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026