Clinical trial NCT01533402: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Cognitive behavior therapy
Internet
Anxiety disorders
Children
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Barn-och ungdomspsykiatrin (BUP), Stockholm
First posted: 2012-02-15
Enrollment: 128
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Anxiety symptoms
timeFrame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Quality of Life
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: comorbidity
timeFrame: two - four weeks before treatment starts
measure: Depressive symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Funtional impairment
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Client Satisfaction Scale
timeFrame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment
measure: Parental psychopathology
timeFrame: two weeks pre treatment
measure: Anxiety symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Anxiety symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Anxiety symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
measure: Anxiety symptoms
timeFrame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Barn-och ungdomspsykiatrin, Stockholm
Study officials:
References:
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.
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.