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

September 4, 2018 updated by: Eva Serlachius, Karolinska Institutet
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 113 30
        • BUP CPF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICBT
Internet-based cognitive behavior therapy
Behavioral: Internet-based CBT
12 weeks of internet-based CBT
No Intervention: Supportive control
Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of DSM Anxiety disorder
Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
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
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
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
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
Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Child version
Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Quality of life
Assessed at Pre, Post, 3-month and 12-month Follow-up
KIDSCREEN-10 Parent version
Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up
Quality of life
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
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
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
Assessed at Pre
Technology Acceptance Scale - Child (TAS-C)
Time Frame: Assessed at Mid-3 weeks and Post
Perceived usefulness and perceived ease of use
Assessed at Mid-3 weeks and Post
Technology Acceptance Scale - Parent (TAS-P)
Time Frame: Assessed at Mid-3 weeks and Post
Perceived usefulness and perceived ease of use
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
Assessed at Pre, Post, 3-month and 12-month Follow-up
Measurement of compliance to exposure assignments and anxiety levels, through mobile app
Time Frame: During the 12 weeks of ICBT
Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app
During the 12 weeks of ICBT
Unintended treatment effects
Time Frame: Assessed at Post
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
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
Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 25, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIPSY RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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