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

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: therapist support; Behavioral: Internet-delivered CBT

• Registration Number: NCT01533402
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention control	therapist support	Weekly support from therapist without CBT-interventions
Internet CBT	Internet-delivered CBT	Internet-delivered cognitive behavioural therapy with therapy support

Primary Outcome Measures

Name	Time	Method
Anxiety symptoms	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 Outcome Measures

Name	Time	Method
Depressive symptoms	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	Children Depression Scale (CDI)
Anxiety symptoms	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).
Quality of Life	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	Quality of Life (QOLI)
comorbidity	two - four weeks before treatment starts	Development and Wellbeing Assessment (DAWBA)
Funtional impairment	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	Children´s Global Assessment Scale (CGAS)
Client Satisfaction Scale	two weeks before treatment and 10 weeks, 3 and 12 months post treatment	Client Satisfaction Scale (CSS)
Parental psychopathology	two weeks pre treatment	Primary Care Evaluation of Mental disorders (Prime-MD)

Trial Locations

Locations (1)

Barn-och ungdomspsykiatrin, Stockholm; 🇸🇪 Stockholm, Sweden