Clinical trial NCT02081365: Clinical Management of Anxiety and Access to Health Care
Official title: Clinical Management of Anxiety and Access to Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2014-03-07
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* high dental anxiety
* fluent in spoken and written English

Exclusion Criteria:

* unable to provide written, informed consent

Primary outcomes:
measure: Change in Modified Dental Anxiety Scale
timeFrame: Change from one week before dentist appointment to 1 month after dentist appointment
Secondary outcomes:
measure: Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
timeFrame: Change from one week before dental appointment to one-month after dental appointment
measure: Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
timeFrame: Change from one week before appointment to one month after appointment
measure: Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
timeFrame: Change from one week before appointment to one month after appointment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Kornberg School of Dentistry
state: Pennsylvania
Study officials:
affiliation: Temple University Kornberg School or Dentistry
name: Marisol Tellez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.