Anxiety DisordersNCT01533402
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
A study testing therapist support and Internet-delivered CBT in people with Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- therapist support and Internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Apr 2014
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
- age between 8 and 12 years,
- ability to read and write Swedish and
- with access to a computer and use of internet.
Who cannot join
- Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial
The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.
- Conditions
- Anxiety Disorders
- Being tested
- therapist support, Internet-delivered CBT
- Keywords
- Cognitive behavior therapy, Internet, Anxiety disorders, Children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapist supportBehavioural
Weekly therapist support without CBT-interventions
Internet-delivered CBTBehavioural
Internet-delivered cognitive behavioural therapy with therapist support
| Study group | Role | What they receive |
|---|---|---|
| Attention control | Placebo comparator | Weekly support from therapist without CBT-interventions Receives: Behavioral: therapist support |
| Internet CBT | Experimental | Internet-delivered cognitive behavioural therapy with therapy support Receives: Behavioral: Internet-delivered CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).
Measured: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Secondary outcomes (11)
Anxiety symptoms
Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Quality of Life
Quality of Life (QOLI)
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
comorbidity
Development and Wellbeing Assessment (DAWBA)
Measured: two - four weeks before treatment starts
Depressive symptoms
Children Depression Scale (CDI)
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Funtional impairment
Children´s Global Assessment Scale (CGAS)
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Client Satisfaction Scale
Client Satisfaction Scale (CSS)
Measured: two weeks before treatment and 10 weeks, 3 and 12 months post treatment
Parental psychopathology
Primary Care Evaluation of Mental disorders (Prime-MD)
Measured: two weeks pre treatment
Anxiety symptoms
Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).
Measured: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Barn-och ungdomspsykiatrin (BUP), Stockholm
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533402
- Sponsor's protocol ID
- 2011/2027-31/5
- Status last verified
- Sep 2014
- First submitted
- 6 Feb 2012
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vigerland S, Serlachius E, Thulin U, Andersson G, Larsson JO, Ljotsson B. Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders. Behav Res Ther. 2017 Mar;90:67-75. doi: 10.1016/j.brat.2016.12.008. Epub 2016 Dec 14.
PubMed 28012300Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.
PubMed 26649465
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01533402
- Acronym / sponsor ID
- 2011/2027-31/5
- Conditions
- Anxiety Disorders
- Keywords
- Cognitive behavior therapy, Internet, Anxiety disorders, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Barn-och ungdomspsykiatrin (BUP), Stockholm
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Feb 2012 (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 investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention control | Placebo comparator | Behavioral: therapist supportWeekly support from therapist without CBT-interventions |
| Internet CBT | Experimental | Behavioral: Internet-delivered CBTInternet-delivered cognitive behavioural therapy with therapy support |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
- age between 8 and 12 years,
- ability to read and write Swedish and
- with access to a computer and use of internet.
Key exclusion criteria (1 listed)
- Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.
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 |
|---|---|---|
| therapist supportWeekly therapist support without CBT-interventions | Behavioural | Attention control |
| Internet-delivered CBTInternet-delivered cognitive behavioural therapy with therapist support | Behavioural | Internet CBT |
Primary outcome
Anxiety symptoms
Time frame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).
11 secondary outcomes
Anxiety symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Quality of Life
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
comorbidity
Time frame: two - four weeks before treatment starts
Depressive symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Funtional impairment
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Client Satisfaction Scale
Time frame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment
Parental psychopathology
Time frame: two weeks pre treatment
Anxiety symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
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 9 Sep 2014.
- Derived from this study: PubMed 28012300Vigerland S, Serlachius E, Thulin U, Andersson G, Larsson JO, Ljotsson B. Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders. Behav Res Ther. 2017 Mar;90:67-75. doi: 10.1016/j.brat.2016.12.008. Epub 2016 Dec 14.
- Derived from this study: PubMed 26649465Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapist support and Internet-delivered CBT in people with Anxiety Disorders, 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 4 inclusion and 1 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 9 Sep 2014. 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. Some participants in this study may receive a placebo. 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?
Anxiety symptoms (time frame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment). 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 NCT01533402, which also lists 2 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 9 Sep 2014.