Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

February 13, 2024 updated by: Shervin Shahnavaz, Karolinska Institutet

Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial

The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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
        • Department of Dental Medicine

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

8 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participant is between 8-15 years of age
  • The patient and parents agree to participate in the research project
  • A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
  • The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
  • Have regularly access to computer and the internet
  • Have the time, the possibility and motivation to work and practice with ICBT 3 hours each week in 12 weeks
  • Parents agree to at least book three visits at the dentist during the 12 weeks treatment
  • Parents agree to exposure for intraoral injection at the dentist even if the child does not need dental treatment but suffers from injection phobia

Exclusion Criteria:

  • Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
  • A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
  • Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
  • Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
  • The participant is undergoing or has planned psychiatric/ psychological examination
  • The participant has current/planed psychological treatments
  • Stressful life experiences during the past 12 months, such as divorce in the family, somatic illness that parent or the psychologist see as an obstacle in the treatment
  • Have received cognitive behavioral treatment for dental anxiety or needle phobia during the past three years

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based cognitive behavioral therapy
The treatment program consists of 12 modules that are offered during 12 weeks on Internet. Modules consist of parental education, psycho-education for the children, exposure, cognitive restructuring and home exercises. A psychologist guides parents and children through the treatment with continuous contact using the message function on the Internet platform that is used.
Behavioral: Internet-based cognitive behavioral therapy
No Intervention: Wait list
Participants are not offered any active controlled psychological interventions but have free access to dental health services, which could involve exposure and other behavioral strategies applied by dental staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Picture guided behavioral approach test, child version
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
post treatment(12 weeks), and follow up (12 months after posttreatment)
Picture guided behavioral approach test, parent version
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care.
post treatment(12 weeks), and follow up (12 months after posttreatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measure changes in child's dentistry related self efficacy
post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (child version)
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in the child's dental anxiety
post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (parent version)
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in the child's dental anxiety according to one of the parents
post treatment(12 weeks), and follow up (12 months after posttreatment)
Kiddie Sads (phobic disorders supplement)
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
The phobic disorders supplement of Kiddie Sads diagnostic interview (Version 1.0 of October 1996) is performed by a psychologist through a telephone interview. The outcome is used to investigate whether the participant fulfill the diagnostic criteria for dentistry related specific phobia according to DSM 4.
post treatment(12 weeks), and follow up (12 months after posttreatment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Self-Efficacy Questionnaire for Dental Anxiety
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measure changes in dentistry related parental self efficacy
post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Negative Cognitions in Dentistry
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measure changes in children's dentistry related negative thoughts.
post treatment(12 weeks), and follow up (12 months after posttreatment)
Injection Phobia Scale for Children
Time Frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measure changes in children's degree of anxiety related to injection
post treatment(12 weeks), and follow up (12 months after posttreatment)

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Shervin Shahnavaz, 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 (Actual)

October 1, 2015

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimated)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIPED20151008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Dental Anxiety

Clinical Trials on Internet-based cognitive behavioral therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe