Clinical trial NCT01798355: Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
Official title: Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental Fear
Dental Phobia
Cognitive Behavior Therapy
Specific Phobia
Children and Adolescents anxiety
Self Efficacy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Eastmaninstitutet
First posted: 2013-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.


Eligibility criteria: Inclusion Criteria:

* The patient and parents agree to participate in the research project
* A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion Criteria:

* The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
* The patient undergoing psychiatric examination and/or psychotherapy
* The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Primary outcomes:
measure: Changes in dental anxiety
timeFrame: 3 months and 12 months from baseline
Secondary outcomes:
measure: Changes in Behavioral Avoidance
timeFrame: 3 months and 12 months from baseline
Other outcomes:
measure: General psychopathology
timeFrame: 3 months, 12 months from baseline
measure: Changes in Self efficacy
timeFrame: 3 months and 12 months from baseline
Locations:
city: Stockholm
country: Sweden
facility: Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet
state: Huddinge
Study officials:
affiliation: Department of Dental Medicine, Karolinska Institutet
name: Göran Dahllöf, PhD
role: STUDY_DIRECTOR
affiliation: Department of Dental Medicine, Karolinska Institutet
name: Shervin Shahnaavz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.