Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

Karolinska Institutet1 site in 1 country131 target enrollmentMarch 2015

ConditionsAnxiety Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: Karolinska Institutet
Enrollment: 131
Locations: 1
Primary Endpoint: Clinician Severity Rating (CSR)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

April 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Eva Serlachius

Associate professor, child psychiatrist, MD

Karolinska Institutet

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

Clinical Global Impression - Improvement (CGI-I)(Assessed at 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)
Measurement of compliance to exposure assignments and anxiety levels, through mobile app(During the 12 weeks of ICBT)
Presence of DSM Anxiety disorder(Assessed at Pre, Post, 3-month and 12-month Follow-up)
Children´s Globas Assessment Scale (CGAS)(Assessed at Pre, Post, 3-month and 12-month Follow-up)
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)
Technology Acceptance Scale - Parent (TAS-P)(Assessed at Mid-3 weeks and Post)
KIDSCREEN-10 Child version(Assessed at Pre, Post, 3-month and 12-month Follow-up)
KIDSCREEN-10 Parent version(Assessed at Pre, Post, 3-month and 12-month Follow-up)
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)
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)
Technology Acceptance Scale - Child (TAS-C)(Assessed at Mid-3 weeks and Post)
Hospital Anxiety and Depression Scale - Parents (HADS)(Assessed at Pre)
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)(Assessed at Pre, 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)