Clinical Management of Anxiety and Access to Health Care

NCT02081365 | Completed Results DMC

• 1 other identifier: 4100054871
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  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

  Change from one week before appointment to one month after appointment

Study Arms (2)

High Anxiety Computerized Dental Anxiety Treatment

EXPERIMENTAL

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

Behavioral: Computerized Dental Anxiety Treatment

High Anxiety Wailist Control

NO INTERVENTION

Interventions

Computerized Dental Anxiety Treatment BEHAVIORAL

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.

High Anxiety Computerized Dental Anxiety Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• high dental anxiety
• fluent in spoken and written English

You may not qualify if:

• unable to provide written, informed consent

Sponsors & Collaborators

• Temple University: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Temple University Kornberg School of Dentistry

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 26202996 DERIVED

Results Point of Contact

• Title: Marisol Tellez M. BDS, MPH, Ph.D
• Organization: Maurice H. Kornberg School of Dentistry, Temple University

marisol@temple.edu

215-707-1773

Study Officials

• Marisol Tellez, Ph.D.

  Temple University Kornberg School or Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: March 7, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)