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

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Barn-och ungdomspsykiatrin (BUP), Stockholm
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01533402
First received: February 6, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Anxiety Disorders
Behavioral: therapist support
Behavioral: Internet-delivered CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Anxiety symptoms [ Time Frame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).

  • Quality of Life [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Quality of Life (QOLI)

  • comorbidity [ Time Frame: two - four weeks before treatment starts ] [ Designated as safety issue: No ]
    Development and Wellbeing Assessment (DAWBA)

  • Depressive symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Children Depression Scale (CDI)

  • Funtional impairment [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Children´s Global Assessment Scale (CGAS)

  • Client Satisfaction Scale [ Time Frame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment ] [ Designated as safety issue: No ]
    Client Satisfaction Scale (CSS)

  • Parental psychopathology [ Time Frame: two weeks pre treatment ] [ Designated as safety issue: No ]
    Primary Care Evaluation of Mental disorders (Prime-MD)

  • Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).

  • Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)

  • Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)

  • Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).


Estimated Enrollment: 128
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Attention control
Weekly support from therapist without CBT-interventions
Behavioral: therapist support
Weekly therapist support without CBT-interventions
Experimental: Internet CBT
Internet-delivered cognitive behavioural therapy with therapy support
Behavioral: Internet-delivered CBT
Internet-delivered cognitive behavioural therapy with therapist support

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533402

Locations
Sweden
Barn-och ungdomspsykiatrin, Stockholm
Stockholm, Sweden, 118 91
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Barn-och ungdomspsykiatrin (BUP), Stockholm
  More Information

No publications provided

Responsible Party: Eva Serlachius, Principal Investigator, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01533402     History of Changes
Other Study ID Numbers: 2011/2027-31/5
Study First Received: February 6, 2012
Last Updated: September 8, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Cognitive behavior therapy
Internet
Anxiety disorders
Children

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 11, 2014