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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIPSY RCT

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