Anxiety Disorders
Conditions
Keywords
cognitive behavior therapy, child, randomized controlled trial, internet
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.
Interventions
BEHAVIORALInternet-based CBT
12 weeks of internet-based CBT
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Severity Rating (CSR) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children´s Globas Assessment Scale (CGAS) | Assessed at Pre, Post, 3-month and 12-month Follow-up | — |
| Clinical Global Impression - Improvement (CGI-I) | Assessed at Post, 3-month and 12-month Follow-up | — |
| Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C) | 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) | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | — |
| KIDSCREEN-10 Child version | Assessed at Pre, Post, 3-month and 12-month Follow-up | Quality of life |
| KIDSCREEN-10 Parent version | Assessed at Pre, Post, 3-month and 12-month Follow-up | Quality of life |
| Education, Work and Social Adjustment Scale - Child version (EWSAS-C) | Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up | — |
| Education, Work and Social Adjustment Scale - Parent version (EWSAS-P) | Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up | — |
| Presence of DSM Anxiety disorder | Assessed at Pre, Post, 3-month and 12-month Follow-up | — |
| Technology Acceptance Scale - Child (TAS-C) | Assessed at Mid-3 weeks and Post | Perceived usefulness and perceived ease of use |
| Technology Acceptance Scale - Parent (TAS-P) | Assessed at Mid-3 weeks and Post | Perceived usefulness and perceived ease of use |
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P) | Assessed at Pre, Post, 3-month and 12-month Follow-up | — |
| Measurement of compliance to exposure assignments and anxiety levels, through mobile app | During the 12 weeks of ICBT | Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app |
| Unintended treatment effects | Assessed at Post | — |
| Specific Phobia Questionnaire - Child version (SPQ-C) | 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) | Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up | — |
| Hospital Anxiety and Depression Scale - Parents (HADS) | Assessed at Pre | — |
Countries
Sweden
Outcome results
None listed