NCT01798355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

February 20, 2013

Last Update Submit

September 13, 2018

Conditions

Dental Anxiety

Keywords

Dental FearDental PhobiaCognitive Behavior TherapySpecific PhobiaChildren and Adolescents anxietySelf Efficacy

Outcome Measures

Primary Outcomes (1)

  • Changes in dental anxiety

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

    3 months and 12 months from baseline

Secondary Outcomes (1)

  • Changes in Behavioral Avoidance

    3 months and 12 months from baseline

Other Outcomes (2)

  • General psychopathology

    3 months, 12 months from baseline

  • Changes in Self efficacy

    3 months and 12 months from baseline

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy

Treatment as usual

ACTIVE COMPARATOR
Behavioral: Treatment As Usual

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

Cognitive Behavioral Therapy
Treatment As UsualBEHAVIORAL

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.

Treatment as usual

Eligibility Criteria

Age7 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

Stockholm, Huddinge, 14104, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 29417092BACKGROUND

  • 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.

    PMID: 29358158BACKGROUND

  • 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.

    PMID: 26147012BACKGROUND

Related Links

MeSH Terms

Conditions

Phobia, Specific

Interventions

Cognitive Behavioral TherapyTherapeutics

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Göran Dahllöf, PhD

    Department of Dental Medicine, Karolinska Institutet

    STUDY DIRECTOR

  • Shervin Shahnaavz, PhD

    Department of Dental Medicine, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 25, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

SE(1)