Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588079
• Other study ID #: KIPED20151008
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Internet-based cognitive behavioral therapy

Locations

Country	Name	City	State
Sweden	Department of Dental Medicine	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental Self-Efficacy Questionnaire for Dental Anxiety	Measure changes in dentistry related parental self efficacy	post treatment(12 weeks), and follow up (12 months after posttreatment)
Other	Children's Negative Cognitions in Dentistry	Measure changes in children's dentistry related negative thoughts.	post treatment(12 weeks), and follow up (12 months after posttreatment)
Other	Injection Phobia Scale for Children	Measure changes in children's degree of anxiety related to injection	post treatment(12 weeks), and follow up (12 months after posttreatment)
Primary	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)
Primary	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	Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )	Measure changes in child's dentistry related self efficacy	post treatment(12 weeks), and follow up (12 months after posttreatment)
Secondary	Children's Fear Survey Schedule - Dental Subscale (child version)	Measures changes in the child's dental anxiety	post treatment(12 weeks), and follow up (12 months after posttreatment)
Secondary	Children's Fear Survey Schedule - Dental Subscale (parent version)	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)
Secondary	Kiddie Sads (phobic disorders supplement)	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)

External Links

•   Registration website