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OpenTrials
Completed

NCT Number: NCT02081365

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).

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Kornberg School of Dentistry

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • high dental anxiety
  • fluent in spoken and written English

Exclusion criteria

  • unable to provide written, informed consent

Treatment and study plan

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.

Primary outcomes

  1. Change in Modified Dental Anxiety Scale

    Time frame: Change from one week before dentist appointment to 1 month after dentist appointment

    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 outcomes

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

    Time frame: Change from one week before dental appointment to one-month after dental appointment

    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.

  2. Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV

    Time frame: Change from one week before appointment to one month after appointment

    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.

  3. Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV

    Time frame: Change from one week before appointment to one month after appointment

    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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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