Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

NCT02588079 | Completed

• 1 other identifier: KIPED20151008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Keywords

Dental Fear; Dental Phobia; Internet based cognitive behavioral therapy; specific phobia; children and adolescents anxiety; Self Efficacy

Outcome Measures

Primary Outcomes (2)

• Picture guided behavioral approach test, child version

  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

  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 Outcomes (4)

• Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )

  post treatment(12 weeks), and follow up (12 months after posttreatment)

• Children's Fear Survey Schedule - Dental Subscale (child version)

  post treatment(12 weeks), and follow up (12 months after posttreatment)

• Children's Fear Survey Schedule - Dental Subscale (parent version)

  post treatment(12 weeks), and follow up (12 months after posttreatment)

• Kiddie Sads (phobic disorders supplement)

  post treatment(12 weeks), and follow up (12 months after posttreatment)

Other Outcomes (3)

• Parental Self-Efficacy Questionnaire for Dental Anxiety

  post treatment(12 weeks), and follow up (12 months after posttreatment)

• Children's Negative Cognitions in Dentistry

  post treatment(12 weeks), and follow up (12 months after posttreatment)

• Injection Phobia Scale for Children

  post treatment(12 weeks), and follow up (12 months after posttreatment)

Study Arms (2)

Internet-based cognitive behavioral therapy

EXPERIMENTAL

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

Wait list

NO INTERVENTION

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.

Interventions

Internet-based cognitive behavioral therapy BEHAVIORAL

Internet-based cognitive behavioral therapy

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Dental Medicine

Stockholm, Huddinge, 14104, Sweden

Location

Related Publications (5)

• Shahnavaz S, Hedman-Lagerlof E, Hasselblad T, Reuterskiold L, Kaldo V, Dahllof G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803.

  PMID: 29358158 BACKGROUND

• Shahnavaz S, Hedman E, Grindefjord M, Reuterskiold L, Dahllof G. Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Oct;1(3):234-243. doi: 10.1177/2380084416661473. Epub 2016 Aug 15.

  PMID: 29417092 BACKGROUND

• Shahnavaz S, Rutley S, Larsson K, Dahllof G. Children and parents' experiences of cognitive behavioral therapy for dental anxiety--a qualitative study. Int J Paediatr Dent. 2015 Sep;25(5):317-26. doi: 10.1111/ipd.12181. Epub 2015 Jul 4.

  PMID: 26147012 BACKGROUND

• Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: 1-year Follow-Up Assessment. JMIR Pediatr Parent. 2025 Sep 17;8:e80376. doi: 10.2196/80376.

  PMID: 40962319 DERIVED

• Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 21;26:e42322. doi: 10.2196/42322.

  PMID: 38381476 DERIVED

Related Links

• Registration website

MeSH Terms

Conditions

Phobia, Specific

Study Officials

• Shervin Shahnavaz, PhD

  Department of Dental Medicine, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

SE (1)