Completed

Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

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What is being tested

Cognitive Behavioral Therapy

+ Treatment As Usual

Behavioral
Who is being recruted

From 7 to 19 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorKarolinska Institutet
Last updated: September 14, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01798355
Principal SponsorKarolinska Institutet
Last updated: September 14, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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
The patient and parents agree to participate in the research project
3 exclusion criteria prevent from participating
The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
The patient has no dental treatment needs or the dental treatment needs are of an emergency nature
The patient undergoing psychiatric examination and/or psychotherapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

Stockholm, SwedenOpen Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet in Google Maps
CompletedOne Study Center