Clinical Management of Anxiety and Access to Health Care

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).

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Computerized Dental Anxiety Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Temple University Kornberg School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• high dental anxiety
• fluent in spoken and written English

Exclusion Criteria:

• unable to provide written, informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Anxiety Computerized Dental Anxiety Treatment; Computer based CBT intervention before the scheduled dental appoinment (1.5 hours)	Behavioral: Computerized 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.
No Intervention: High Anxiety Wailist Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from one week before dentist appointment to 1 month after dentist appointment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from one week before dental appointment to one-month after dental appointment
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.	Change from one week before appointment to one month after appointment
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.	Change from one week before appointment to one month after appointment

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Marisol Tellez, Ph.D., Temple University Kornberg School or Dentistry

Publications and helpful links

General Publications

• Tellez M, Potter CM, Kinner DG, Jensen D, Waldron E, Heimberg RG, Myers Virtue S, Zhao H, Ismail AI. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):174S-80S. doi: 10.1177/0022034515598134. Epub 2015 Jul 22.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 4100054871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO