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

Karolinska Institutet131 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

131

Conditions

Anxiety Disorders

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment

Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

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

Quality of life

Time frame: Assessed at Pre, Post, 3-month and 12-month Follow-up

KIDSCREEN-10 Parent version

Quality of life

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)

Perceived usefulness and perceived ease of use

Time frame: Assessed at Mid-3 weeks and Post

Technology Acceptance Scale - Parent (TAS-P)

Perceived usefulness and perceived ease of use

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

Participants register anxiety levels in adjunction to exposure exercises, with a smartphone 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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes