Dental AnxietyNCT02588079
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
A study testing Internet-based cognitive behavioral therapy in people with Dental Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Internet-based cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant is between 8-15 years of age
- The patient and parents agree to participate in the research project
- A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
- The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
- Have regularly access to computer and the internet
- Have the time, the possibility and motivation to work and practice with ICBT 3 hours each week in 12 weeks
- Parents agree to at least book three visits at the dentist during the 12 weeks treatment
- Parents agree to exposure for intraoral injection at the dentist even if the child does not need dental treatment but suffers from injection phobia
Who cannot join
- Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
- A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
- Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
- Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
- The participant is undergoing or has planned psychiatric/ psychological examination
- The participant has current/planed psychological treatments
- Stressful life experiences during the past 12 months, such as divorce in the family, somatic illness that parent or the psychologist see as an obstacle in the treatment
- Have received cognitive behavioral treatment for dental anxiety or needle phobia during the past three years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial
The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.
- Conditions
- Dental Anxiety
- Being tested
- Internet-based cognitive behavioral therapy
- Keywords
- Dental Fear, Dental Phobia, Internet based cognitive behavioral therapy, specific phobia, children and adolescents anxiety, Self Efficacy
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | The treatment program consists of 12 modules that are offered during 12 weeks on Internet. Modules consist of parental education, psycho-education for the children, exposure, cognitive restructuring and home exercises. A psychologist guides parents and children through the treatment with continuous contact using the message function on the Internet platform that is used. Receives: Behavioral: Internet-based cognitive behavioral therapy |
| Wait list | No intervention | Participants are not offered any active controlled psychological interventions but have free access to dental health services, which could involve exposure and other behavioral strategies applied by dental staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture guided behavioral approach test, child version
Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Picture guided behavioral approach test, parent version
Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care.
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Secondary outcomes (4)
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
Measure changes in child's dentistry related self efficacy
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (child version)
Measures changes in the child's dental anxiety
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (parent version)
Measures changes in the child's dental anxiety according to one of the parents
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Kiddie Sads (phobic disorders supplement)
The phobic disorders supplement of Kiddie Sads diagnostic interview (Version 1.0 of October 1996) is performed by a psychologist through a telephone interview. The outcome is used to investigate whether the participant fulfill the diagnostic criteria for dentistry related specific phobia according to DSM 4.
Measured: post treatment(12 weeks), and follow up (12 months after posttreatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shervin Shahnavaz, Karolinska Institutet
- Investigators
- Shervin Shahnavaz, PhD, Principal investigator, Department of Dental Medicine, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588079
- Sponsor's protocol ID
- KIPED20151008
- Status last verified
- Feb 2024
- First submitted
- 22 Oct 2015
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29358158Shahnavaz 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.
PubMed 29417092Shahnavaz 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.
PubMed 26147012Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: 1-year Follow-Up Assessment. JMIR Pediatr Parent. 2025 Sep 17;8:e80376. doi: 10.2196/80376.
PubMed 40962319Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 21;26:e42322. doi: 10.2196/42322.
PubMed 38381476
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02588079
- Acronym / sponsor ID
- KIPED20151008
- Conditions
- Dental Anxiety
- Keywords
- Dental Fear, Dental Phobia, Internet based cognitive behavioral therapy, specific phobia, children and adolescents anxiety, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | Behavioral: Internet-based cognitive behavioral therapyThe treatment program consists of 12 modules that are offered during 12 weeks on Internet. Modules consist of parental education, psycho-education for the children, exposure, cognitive restructuring and home exercises. A psychologist guides parents and children through the treatment with continuous contact using the message function on the Internet platform that is used. |
| Wait list | No intervention | –Participants are not offered any active controlled psychological interventions but have free access to dental health services, which could involve exposure and other behavioral strategies applied by dental staff. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The participant is between 8-15 years of age
- The patient and parents agree to participate in the research project
- A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
- The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
- Have regularly access to computer and the internet
Key exclusion criteria (8 listed)
- Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
- A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
- Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
- Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
- The participant is undergoing or has planned psychiatric/ psychological examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavioral therapy | Behavioural | Internet-based cognitive behavioral therapy |
Primary outcome
Picture guided behavioral approach test, child version
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.
Picture guided behavioral approach test, parent version
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care.
4 secondary outcomes
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (child version)
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Children's Fear Survey Schedule - Dental Subscale (parent version)
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Kiddie Sads (phobic disorders supplement)
Time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 29358158Shahnavaz 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.
- Background: PubMed 29417092Shahnavaz 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.
- Background: PubMed 26147012Shahnavaz 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.
- Derived from this study: PubMed 40962319Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: 1-year Follow-Up Assessment. JMIR Pediatr Parent. 2025 Sep 17;8:e80376. doi: 10.2196/80376.
- Derived from this study: PubMed 38381476Schibbye R, Hedman-Lagerlof E, Kaldo V, Dahllof G, Shahnavaz S. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 21;26:e42322. doi: 10.2196/42322.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shervin Shahnavaz, PhD principal investigator
Department of Dental Medicine, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy in people with Dental Anxiety, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture guided behavioral approach test, child version (time frame: post treatment(12 weeks), and follow up (12 months after posttreatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588079, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.