Clinical trial NCT02350257: Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Official title: Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: cognitive behavior therapy
child
randomized controlled trial
internet
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 131
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Clinician Severity Rating (CSR)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary outcomes:
measure: Presence of DSM Anxiety disorder
timeFrame: Assessed at Pre, Post, 3-month and 12-month Follow-up
measure: Children´s Globas Assessment Scale (CGAS)
timeFrame: Assessed at Pre, Post, 3-month and 12-month Follow-up
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Assessed at Post, 3-month and 12-month Follow-up
measure: Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)
timeFrame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
measure: Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)
timeFrame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
measure: KIDSCREEN-10 Child version
timeFrame: Assessed at Pre, Post, 3-month and 12-month Follow-up
measure: KIDSCREEN-10 Parent version
timeFrame: Assessed at Pre, Post, 3-month and 12-month Follow-up
measure: Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
timeFrame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
measure: Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
timeFrame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
measure: Hospital Anxiety and Depression Scale - Parents (HADS)
timeFrame: Assessed at Pre
measure: Technology Acceptance Scale - Child (TAS-C)
timeFrame: Assessed at Mid-3 weeks and Post
measure: Technology Acceptance Scale - Parent (TAS-P)
timeFrame: Assessed at Mid-3 weeks and Post
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
timeFrame: Assessed at Pre, Post, 3-month and 12-month Follow-up
measure: Measurement of compliance to exposure assignments and anxiety levels, through mobile app
timeFrame: During the 12 weeks of ICBT
measure: Unintended treatment effects
timeFrame: Assessed at Post
measure: Specific Phobia Questionnaire - Child version (SPQ-C)
timeFrame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
measure: Specific Phobia Questionnaire - Parent version (SPQ-P)
timeFrame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP CPF
Study officials:
References:
citation: 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.