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Clinical Management of Anxiety and Access to Health Care

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Dental Anxiety Treatment
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • high dental anxiety
  • fluent in spoken and written English

Exclusion Criteria:

  • unable to provide written, informed consent

Sites / Locations

  • Temple University Kornberg School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High Anxiety Computerized Dental Anxiety Treatment

High Anxiety Wailist Control

Arm Description

Computer based CBT intervention before the scheduled dental appoinment (1.5 hours)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
December 17, 2013
Last Updated
December 2, 2016
Sponsor
Temple University
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT02081365
Brief Title
Clinical Management of Anxiety and Access to Health Care
Official Title
Clinical Management of Anxiety and Access to Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Pennsylvania Department of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Anxiety Computerized Dental Anxiety Treatment
Arm Type
Experimental
Arm Description
Computer based CBT intervention before the scheduled dental appoinment (1.5 hours)
Arm Title
High Anxiety Wailist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized Dental Anxiety Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Modified Dental Anxiety Scale
Description
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
Secondary Outcome Measure Information:
Title
Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Description
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
Title
Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Description
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
Title
Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: high dental anxiety fluent in spoken and written English Exclusion Criteria: unable to provide written, informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisol Tellez, Ph.D.
Organizational Affiliation
Temple University Kornberg School or Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Kornberg School of Dentistry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26202996
Citation
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.
Results Reference
derived

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Clinical Management of Anxiety and Access to Health Care

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