Cognitive Behavioural Treatment of Intra-oral Injection-phobia in 10-16 Year Old Children and Adolescents

NCT02083432 | Completed DMC

• 1 other identifier: 2010/63
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the study: to explore the possible effectiveness of cognitive behavior treatment (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia (DSM-IV), when performed by specially trained dentists. The patients diagnosed with intra-oral injection phobia according to the diagnostic manual DSM-IV. The effect of cognitive behavior therapy when performed by specially trained dentists will be evaluated. Patients referred to the Centre for Odontophobia, and who meet the inclusion criteria, will be allocated to an immediate treatment group (test group) and a waiting list group (control group) of 30 subjects in each group. After treatment they will be followed up during a 1-year period. Hypotheses are formulated based on the literature and previous population and treatment studies of similar designs among adults at the Centre for Odontophobia.

Conditions

Dental Anxiety

Keywords

intra-oral injections; CBT; Blood-Injury-Injection-phobia; DSM-IV. 300.29

Outcome Measures

Primary Outcomes (1)

• Intra-oral injection-phobia in children and adolescents. Prevalence, subgroups and the effect of cognitive behavioral treatment (CBT)

  Outcome measure: to evaluate whether children and adolescents diagnosed with intraoral injection phobia and treated with CBT, will be able to receive intraoral injections at an external dentist at 1 year follow-up.

  at 1 year follow-up

Study Arms (2)

5-weeks waiting list control

ACTIVE COMPARATOR

Half of the participants were randomly assigned to 5-weeks waiting list/Control group.The participants in the waiting list/Control Group are enrolled to the treatment Group (INtervention: 5 sessions of CBT) after 5 weeks if they still meet the diagnostic criteria of a specific phobia (according to DSM-IV).

Behavioral: 5 session of CBT performed by specially trained dentists

5 session of CBT

EXPERIMENTAL

Half of the participants were direct enrolled to 5 weeks(5 sessions) of cognitive behaviour therapy (CBT) performed by specially trained dentists. (Intervention: CBT)

Behavioral: 5 session of CBT performed by specially trained dentists

Interventions

5 session of CBT performed by specially trained dentists BEHAVIORAL

A total of 60 participants are randomly assigned to a 5-weeks waiting list Control Group or directly enrolled to the 5-session of CBT treatment Group. The participants in the waiting list Control Group are enrolled to the treatment Group (5 sessions of CBT) after 5 weeks if they still meet the diagnostic criteria of a specific phobia (according to DSM-IV).

5 session of CBT; 5-weeks waiting list control

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 10 and 16 years old diagnosed by clinical psychologist with Intra-oral injection phobia (DSM-IV 300.29).
• All patients refused to have intra-oral injections in Public Dental Health Clinics.
• Phobia of injections had to be the main phobia during dental treatment.

You may not qualify if:

• Accept anaesthetic infiltration during behavioural approach test.
• Cognitive impairment.
• Refuse to participate according to the study protocol.

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, 5009, Norway

Location

Study Officials

• Marit S Skeie, Professor

  University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UBergen

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 11, 2014
• Study Start: December 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

NO (1)