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Clinical Trials/NCT01533402
NCT01533402
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country128 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Karolinska Institutet
Enrollment
128
Locations
1
Primary Endpoint
Anxiety symptoms
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
April 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva Serlachius

Principal Investigator, MD, PhD

Karolinska Institutet

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Funtional impairment(two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment)
  • Depressive symptoms(two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment)
  • Anxiety symptoms(two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment)
  • Quality of Life(two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment)
  • comorbidity(two - four weeks before treatment starts)
  • Client Satisfaction Scale(two weeks before treatment and 10 weeks, 3 and 12 months post treatment)
  • Parental psychopathology(two weeks pre treatment)

Study Sites (1)

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