Anxiety DisordersNCT02350257
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
A study testing Internet-based CBT in people with Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific… 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?
- Internet-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Apr 2018
- 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
- A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)
- Age between 8 and 12 years
- Ability to read and write Swedish
- Daily access to the internet
- A parent that is able to co-participate in the treatment
- Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Who cannot join
- Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
- Present risk of suicide
- Ongoing substance dependence
- Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.
- Conditions
- Anxiety Disorders
- Being tested
- Internet-based CBT
- Keywords
- cognitive behavior therapy, child, randomized controlled trial, internet
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBTBehavioural
12 weeks of internet-based CBT
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Experimental | Internet-based cognitive behavior therapy Receives: Behavioral: Internet-based CBT |
| Supportive control | No intervention | Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Severity Rating (CSR)
Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary outcomes (17)
Presence of DSM Anxiety disorder
Measured: Assessed at Pre, Post, 3-month and 12-month Follow-up
Children´s Globas Assessment Scale (CGAS)
Measured: Assessed at Pre, Post, 3-month and 12-month Follow-up
Clinical Global Impression - Improvement (CGI-I)
Measured: Assessed at Post, 3-month and 12-month Follow-up
Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)
Measured: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)
Measured: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Child version
Quality of life
Measured: Assessed at Pre, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Parent version
Quality of life
Measured: Assessed at Pre, Post, 3-month and 12-month Follow-up
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Measured: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Measured: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Hospital Anxiety and Depression Scale - Parents (HADS)
Measured: Assessed at Pre
Technology Acceptance Scale - Child (TAS-C)
Perceived usefulness and perceived ease of use
Measured: Assessed at Mid-3 weeks and Post
Technology Acceptance Scale - Parent (TAS-P)
Perceived usefulness and perceived ease of use
Measured: Assessed at Mid-3 weeks and Post
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
Measured: Assessed at Pre, Post, 3-month and 12-month Follow-up
Measurement of compliance to exposure assignments and anxiety levels, through mobile app
Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app
Measured: During the 12 weeks of ICBT
Unintended treatment effects
Measured: Assessed at Post
Specific Phobia Questionnaire - Child version (SPQ-C)
Measured: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Specific Phobia Questionnaire - Parent version (SPQ-P)
Measured: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350257
- Sponsor's protocol ID
- BIPSY RCT
- Status last verified
- Sep 2018
- First submitted
- 19 Jan 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jolstedt M, Wahlund T, Lenhard F, Ljotsson B, Mataix-Cols D, Nord M, Ost LG, Hogstrom J, Serlachius E, Vigerland S. Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018 Nov;2(11):792-801. doi: 10.1016/S2352-4642(18)30275-X. Epub 2018 Sep 18.
PubMed 30241993
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
- ClinicalTrials.gov ID
- NCT02350257
- Acronym / sponsor ID
- BIPSY RCT
- Conditions
- Anxiety Disorders
- Keywords
- cognitive behavior therapy, child, randomized controlled trial, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Jan 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 primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT | Experimental | Behavioral: Internet-based CBTInternet-based cognitive behavior therapy |
| Supportive control | No intervention | –Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)
- Age between 8 and 12 years
- Ability to read and write Swedish
- Daily access to the internet
- A parent that is able to co-participate in the treatment
Key exclusion criteria (4 listed)
- Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
- Present risk of suicide
- Ongoing substance dependence
- Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
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 CBT12 weeks of internet-based CBT | Behavioural | ICBT |
Primary outcome
Clinician Severity Rating (CSR)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment
17 secondary outcomes
Presence of DSM Anxiety disorder
Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Children´s Globas Assessment Scale (CGAS)
Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Clinical Global Impression - Improvement (CGI-I)
Time frame: Assessed at Post, 3-month and 12-month Follow-up
Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)
Time frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)
Time frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Child version
Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Parent version
Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Time frame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Time frame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Hospital Anxiety and Depression Scale - Parents (HADS)
Time frame: Assessed at Pre
Technology Acceptance Scale - Child (TAS-C)
Time frame: Assessed at Mid-3 weeks and Post
Technology Acceptance Scale - Parent (TAS-P)
Time frame: Assessed at Mid-3 weeks and Post
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Measurement of compliance to exposure assignments and anxiety levels, through mobile app
Time frame: During the 12 weeks of ICBT
Unintended treatment effects
Time frame: Assessed at Post
Specific Phobia Questionnaire - Child version (SPQ-C)
Time frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Specific Phobia Questionnaire - Parent version (SPQ-P)
Time frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
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 6 Sep 2018.
- Derived from this study: PubMed 30241993Jolstedt M, Wahlund T, Lenhard F, Ljotsson B, Mataix-Cols D, Nord M, Ost LG, Hogstrom J, Serlachius E, Vigerland S. Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018 Nov;2(11):792-801. doi: 10.1016/S2352-4642(18)30275-X. Epub 2018 Sep 18.
- BarninternetprojektetLink provided by the sponsor.
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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 Internet-based 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 6 inclusion and 4 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 6 Sep 2018. 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?
Clinician Severity Rating (CSR) (time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended). 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 NCT02350257, which also lists 1 linked publication.
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 6 Sep 2018.