Clinical Management of Anxiety and Access to Health Care

Dental Anxiety Clinical Trial

Official title:

Clinical Management of Anxiety and Access to Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081365
• Other study ID #: 4100054871
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: July 29, 2015
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. The goal of this project is to develop a computer-administered dental anxiety management program that can easily be implemented in dental health care settings. Our aim is for this management program to: 1) integrate different treatments modalities such as cognitive-behavioral therapy (CBT) and motivational interviewing (MI) into one computer-based protocol; 2) facilitate patient adherence to this protocol; 3) lend itself to empirical validation; and 4) lend itself to dissemination to other research and treatment settings. A randomized controlled trial (RCT) will be conducted (n=200). Based on the subjects responses to the screening questionnaires, consenting dental patients at Temple University Kornberg School of Dentistry will be assigned to one of 2 possible groups, (1) high dental anxiety and (2) low dental anxiety. The intervention package will be delivered to a randomly selected half of participants in group 1 (high anxiety group), whereas the remaining participants in this group will be assigned to a delayed treatment control condition. The low dental anxiety patients (group 2) will be used as a benchmark against which to compare post-treatment (or post-control) outcomes for the high anxiety patients. We hope to develop an intervention that can be easily implemented in a broader context without the need for highly specialized personnel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• high dental anxiety

• fluent in spoken and written English

Exclusion Criteria:

• unable to provide written, informed consent

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Temple University Kornberg School of Dentistry	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Dental Anxiety Scale		Change from one week before intervention to 1 month after intervention	No
Primary	Change in Anxiety Disorders Interview Schedule for DSM-IV		Change from one week before intervention to one-month after intervention	No