ClinicalTrials.gov
ClinicalTrials.gov Menu

Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02588079
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Shervin Shahnavaz, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Behavioral: Internet-based cognitive behavioral therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588079


Contacts
Contact: Shervin Shahnavaz, PhD +46-722154769 shervin.shahnavaz@ki.se
Contact: Robert Schibbye, MS robert.schibbye@ki.se

Locations
Sweden
Department of Dental Medicine Recruiting
Stockholm, Huddinge, Sweden, 14104
Contact: Shervin Shahnavaz, PhD    +46-722154769    shervin.shahnavaz@ki.se   
Contact: Robert Schibbye, MS       robert.schibbye@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Shervin Shahnavaz, PhD Department of Dental Medicine, Karolinska Institutet

Additional Information:
Publications:
Responsible Party: Shervin Shahnavaz, Psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02588079     History of Changes
Other Study ID Numbers: KIPED20151008
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Keywords provided by Shervin Shahnavaz, Karolinska Institutet:
Dental Fear
Dental Phobia
Internet based cognitive behavioral therapy
specific phobia
children and adolescents anxiety
Self Efficacy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders