Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders

September 8, 2014 updated by: Eva Serlachius, Karolinska Institutet

Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial

The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

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, 118 91
        • Barn-och ungdomspsykiatrin, Stockholm

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:

  • primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
  • age between 8 and 12 years,
  • ability to read and write Swedish and
  • with access to a computer and use of internet.

Exclusion Criteria:

  • Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Attention control
Weekly support from therapist without CBT-interventions
Behavioral: therapist support
Weekly therapist support without CBT-interventions
Experimental: Internet CBT
Internet-delivered cognitive behavioural therapy with therapy support
Behavioral: Internet-delivered CBT
Internet-delivered cognitive behavioural therapy with therapist support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms
Time Frame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).
two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Quality of Life
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Quality of Life (QOLI)
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
comorbidity
Time Frame: two - four weeks before treatment starts
Development and Wellbeing Assessment (DAWBA)
two - four weeks before treatment starts
Depressive symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Children Depression Scale (CDI)
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Funtional impairment
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Children´s Global Assessment Scale (CGAS)
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Client Satisfaction Scale
Time Frame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment
Client Satisfaction Scale (CSS)
two weeks before treatment and 10 weeks, 3 and 12 months post treatment
Parental psychopathology
Time Frame: two weeks pre treatment
Primary Care Evaluation of Mental disorders (Prime-MD)
two weeks pre treatment
Anxiety symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Anxiety symptoms
Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm
Barn-och ungdomspsykiatrin (BUP), Stockholm

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

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

February 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2027-31/5

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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