Skip to main content
OpenTrials
Completed

NCT Number: NCT01533402

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barn-och ungdomspsykiatrin, Stockholm

Stockholm, 118 91, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapist support

Behavioral

Weekly therapist support without CBT-interventions

Internet-delivered CBT

Behavioral

Internet-delivered cognitive behavioural therapy with therapist support

Primary outcomes

  1. 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

  1. Anxiety symptoms

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).

  2. Quality of Life

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Quality of Life (QOLI)

  3. comorbidity

    Time frame: two - four weeks before treatment starts

    Development and Wellbeing Assessment (DAWBA)

  4. Depressive symptoms

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Children Depression Scale (CDI)

  5. Funtional impairment

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Children´s Global Assessment Scale (CGAS)

  6. Client Satisfaction Scale

    Time frame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment

    Client Satisfaction Scale (CSS)

  7. Parental psychopathology

    Time frame: two weeks pre treatment

    Primary Care Evaluation of Mental disorders (Prime-MD)

  8. Anxiety symptoms

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).

  9. Anxiety symptoms

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)

  10. Anxiety symptoms

    Time frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

    Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)

  11. Anxiety symptoms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Barn-och ungdomspsykiatrin (BUP), Stockholm
  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2012
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.