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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533402
• Other study ID #: 2011/2027-31/5
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: September 8, 2014
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• therapist support
Weekly therapist support without CBT-interventions
• Internet-delivered CBT
Internet-delivered cognitive behavioural therapy with therapist support

Locations

Country	Name	City	State
Sweden	Barn-och ungdomspsykiatrin, Stockholm	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Barn-och ungdomspsykiatrin (BUP), Stockholm, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety symptoms	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	No
Secondary	Anxiety symptoms	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	No
Secondary	Quality of Life	Quality of Life (QOLI)	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	No
Secondary	comorbidity	Development and Wellbeing Assessment (DAWBA)	two - four weeks before treatment starts	No
Secondary	Depressive symptoms	Children Depression Scale (CDI)	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	No
Secondary	Funtional impairment	Children´s Global Assessment Scale (CGAS)	two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment	No
Secondary	Client Satisfaction Scale	Client Satisfaction Scale (CSS)	two weeks before treatment and 10 weeks, 3 and 12 months post treatment	No
Secondary	Parental psychopathology	Primary Care Evaluation of Mental disorders (Prime-MD)	two weeks pre treatment	No
Secondary	Anxiety symptoms	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	No
Secondary	Anxiety symptoms	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	No
Secondary	Anxiety symptoms	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	No
Secondary	Anxiety symptoms	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	No