Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

Sponsor

Karolinska Institutet (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02588079

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

33 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

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Picture guided behavioral approach test, child version [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.
Picture guided behavioral approach test, parent version [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

Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version ) [post treatment(12 weeks), and follow up (12 months after posttreatment)]
Measure changes in child's dentistry related self efficacy
Children's Fear Survey Schedule - Dental Subscale (child version) [post treatment(12 weeks), and follow up (12 months after posttreatment)]
Measures changes in the child's dental anxiety
Children's Fear Survey Schedule - Dental Subscale (parent version) [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
Kiddie Sads (phobic disorders supplement) [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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