Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

September 13, 2018 updated by: Shervin Shahnavaz, Karolinska Institutet
The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden, 14104
        • Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient and parents agree to participate in the research project
  • A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion Criteria:

  • The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
  • The patient undergoing psychiatric examination and/or psychotherapy
  • The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Behavioral: Treatment As Usual
Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.
Experimental: Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy
The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dental anxiety
Time Frame: 3 months and 12 months from baseline
Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.
3 months and 12 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Behavioral Avoidance
Time Frame: 3 months and 12 months from baseline
Behavioral Avoidance Test consists of 18 dental situations. The patient is exposed to a situation at a time. Patients receive 1 point for every step he / she manage. The test is stopped when the patient does not want to go further.
3 months and 12 months from baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General psychopathology
Time Frame: 3 months, 12 months from baseline
Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire
3 months, 12 months from baseline
Changes in Self efficacy
Time Frame: 3 months and 12 months from baseline
Self Efficacy is assessed by the Self Efficacy Questionnaire for Specific Phobias
3 months and 12 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden

Investigators

  • Study Director: Göran Dahllöf, PhD, Department of Dental Medicine, Karolinska Institutet
  • Principal Investigator: Shervin Shahnaavz, PhD, Department of Dental Medicine, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIPED20130218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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