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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
therapist support
Internet-delivered CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Cognitive behavior therapy, Internet, Anxiety disorders, Children

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barn-och ungdomspsykiatrin, Stockholm

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Attention control

Internet CBT

Arm Description

Weekly support from therapist without CBT-interventions

Internet-delivered cognitive behavioural therapy with therapy support

Outcomes

Primary Outcome Measures

Anxiety symptoms
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

Anxiety symptoms
Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).
Quality of Life
Quality of Life (QOLI)
comorbidity
Development and Wellbeing Assessment (DAWBA)
Depressive symptoms
Children Depression Scale (CDI)
Funtional impairment
Children´s Global Assessment Scale (CGAS)
Client Satisfaction Scale
Client Satisfaction Scale (CSS)
Parental psychopathology
Primary Care Evaluation of Mental disorders (Prime-MD)
Anxiety symptoms
Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).
Anxiety symptoms
Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)
Anxiety symptoms
Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)
Anxiety symptoms
Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).

Full Information

First Posted
February 6, 2012
Last Updated
September 8, 2014
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Barn-och ungdomspsykiatrin (BUP), Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01533402
Brief Title
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
Official Title
Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Barn-och ungdomspsykiatrin (BUP), Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Cognitive behavior therapy, Internet, Anxiety disorders, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
Weekly support from therapist without CBT-interventions
Arm Title
Internet CBT
Arm Type
Experimental
Arm Description
Internet-delivered cognitive behavioural therapy with therapy support
Intervention Type
Behavioral
Intervention Name(s)
therapist support
Intervention Description
Weekly therapist support without CBT-interventions
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT
Intervention Description
Internet-delivered cognitive behavioural therapy with therapist support
Primary Outcome Measure Information:
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).
Time Frame
two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Secondary Outcome Measure Information:
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Quality of Life
Description
Quality of Life (QOLI)
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
comorbidity
Description
Development and Wellbeing Assessment (DAWBA)
Time Frame
two - four weeks before treatment starts
Title
Depressive symptoms
Description
Children Depression Scale (CDI)
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Funtional impairment
Description
Children´s Global Assessment Scale (CGAS)
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Client Satisfaction Scale
Description
Client Satisfaction Scale (CSS)
Time Frame
two weeks before treatment and 10 weeks, 3 and 12 months post treatment
Title
Parental psychopathology
Description
Primary Care Evaluation of Mental disorders (Prime-MD)
Time Frame
two weeks pre treatment
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Title
Anxiety symptoms
Description
Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).
Time Frame
two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Barn-och ungdomspsykiatrin, Stockholm
City
Stockholm
ZIP/Postal Code
118 91
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28012300
Citation
Vigerland S, Serlachius E, Thulin U, Andersson G, Larsson JO, Ljotsson B. Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders. Behav Res Ther. 2017 Mar;90:67-75. doi: 10.1016/j.brat.2016.12.008. Epub 2016 Dec 14.
Results Reference
derived
PubMed Identifier
26649465
Citation
Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.
Results Reference
derived

Learn more about this trial

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

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