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

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Internet-based CBT

• Registration Number: NCT02350257
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-25
• Study First Posted: 2015-01-29
• Study Start: 2015-03
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICBT	Internet-based CBT	Internet-based cognitive behavior therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app
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	Perceived usefulness and perceived ease of use
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
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	Perceived usefulness and perceived ease of use
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

Trial Locations

Locations (1)

BUP CPF; 🇸🇪 Stockholm, Sweden