Back to results

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

Primary Purpose

Dental Anxiety

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

Treatment As Usual

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring Dental Fear, Dental Phobia, Cognitive Behavior Therapy, Specific Phobia, Children and Adolescents anxiety, Self Efficacy

Eligibility Criteria

7 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Changes in dental anxiety

Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.

Secondary Outcome Measures

Changes in Behavioral Avoidance

Behavioral Avoidance Test consists of 18 dental situations. The patient is exposed to a situation at a time. Patients receive 1 point for every step he / she manage. The test is stopped when the patient does not want to go further.

Full Information

NCT ID

NCT01798355

First Posted

February 20, 2013

Last Updated

September 13, 2018

Sponsor

Karolinska Institutet

Collaborators

Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT01798355

Brief Title

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

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Anxiety

Keywords

Dental Fear, Dental Phobia, Cognitive Behavior Therapy, Specific Phobia, Children and Adolescents anxiety, Self Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Title

Treatment as usual

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Treatment As Usual

Intervention Description

Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.

Primary Outcome Measure Information:

Title

Changes in dental anxiety

Description

Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.

Time Frame

3 months and 12 months from baseline

Secondary Outcome Measure Information:

Title

Changes in Behavioral Avoidance

Description

Time Frame

3 months and 12 months from baseline

Other Pre-specified Outcome Measures:

Title

General psychopathology

Description

Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire

Time Frame

3 months, 12 months from baseline

Title

Changes in Self efficacy

Description

Self Efficacy is assessed by the Self Efficacy Questionnaire for Specific Phobias

Time Frame

3 months and 12 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Göran Dahllöf, PhD

Organizational Affiliation

Department of Dental Medicine, Karolinska Institutet

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shervin Shahnaavz, PhD

Organizational Affiliation

Department of Dental Medicine, Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

City

Stockholm

State/Province

Huddinge

ZIP/Postal Code

14104

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

29417092

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.

Results Reference

background

PubMed Identifier

29358158

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.

Results Reference

background

PubMed Identifier

26147012

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.

Results Reference

background

Links:

URL

http://ki.se/dentmed/kbt

Description

Registration website for our study of Internet-based CBT for pediatric dentala anxiety study

Learn more about this trial

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

We'll reach out to this number within 24 hrs