Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Anxiety symptoms
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Attention control
Weekly support from therapist without CBT-interventions
Intervention: therapist support (Behavioral)
Internet CBT
Internet-delivered cognitive behavioural therapy with therapy support
Intervention: Internet-delivered CBT (Behavioral)
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)
- Client Satisfaction Scale(two weeks before treatment and 10 weeks, 3 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)
- Parental psychopathology(two weeks pre treatment)
- Depressive symptoms(two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment)
Investigators
Eva Serlachius
Principal Investigator, MD, PhD
Karolinska Institutet