Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

NCT ID: NCT02588079

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Internet-based cognitive behavioral therapy

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-based cognitive behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Shervin Shahnavaz

Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shervin Shahnavaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dental Medicine, Karolinska Institutet

Locations

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Department of Dental Medicine

Stockholm, Huddinge, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 29358158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29417092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26147012 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40962319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38381476 (View on PubMed)

Related Links

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http://ki.se/dentmed/kbt

Registration website

Other Identifiers

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KIPED20151008

Identifier Type: -

Identifier Source: org_study_id

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