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Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

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ClinicalTrials.gov Identifier: NCT02350257
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet

Brief Summary:
The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Internet-based CBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Study Start Date : March 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: ICBT
Internet-based cognitive behavior therapy
Behavioral: Internet-based CBT
12 weeks of internet-based CBT

No Intervention: Supportive control
Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety.



Primary Outcome Measures :
  1. Clinician Severity Rating (CSR) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment


Secondary Outcome Measures :
  1. Presence of DSM Anxiety disorder [ Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up ]
  2. Children´s Globas Assessment Scale (CGAS) [ Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up ]
  3. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Assessed at Post, 3-month and 12-month Follow-up ]
  4. Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C) [ Time Frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up ]
  5. Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P) [ Time Frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up ]
  6. KIDSCREEN-10 Child version [ Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up ]
    Quality of life

  7. KIDSCREEN-10 Parent version [ Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up ]
    Quality of life

  8. Education, Work and Social Adjustment Scale - Child version (EWSAS-C) [ Time Frame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up ]
  9. Education, Work and Social Adjustment Scale - Parent version (EWSAS-P) [ Time Frame: Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up ]
  10. Hospital Anxiety and Depression Scale - Parents (HADS) [ Time Frame: Assessed at Pre ]
  11. Technology Acceptance Scale - Child (TAS-C) [ Time Frame: Assessed at Mid-3 weeks and Post ]
    Perceived usefulness and perceived ease of use

  12. Technology Acceptance Scale - Parent (TAS-P) [ Time Frame: Assessed at Mid-3 weeks and Post ]
    Perceived usefulness and perceived ease of use

  13. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P) [ Time Frame: Assessed at Pre, Post, 3-month and 12-month Follow-up ]
  14. Measurement of compliance to exposure assignments and anxiety levels, through mobile app [ Time Frame: During the 12 weeks of ICBT ]
    Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app

  15. Unintended treatment effects [ Time Frame: Assessed at Post ]
  16. Specific Phobia Questionnaire - Child version (SPQ-C) [ Time Frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up ]
  17. Specific Phobia Questionnaire - Parent version (SPQ-P) [ Time Frame: Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)
  • Age between 8 and 12 years
  • Ability to read and write Swedish
  • Daily access to the internet
  • A parent that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

  • Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
  • Present risk of suicide
  • Ongoing substance dependence
  • Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350257


Locations
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Sweden
BUP CPF
Stockholm, Sweden, 113 30
Sponsors and Collaborators
Karolinska Institutet

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Serlachius, Associate professor, child psychiatrist, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02350257     History of Changes
Other Study ID Numbers: BIPSY RCT
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by Eva Serlachius, Karolinska Institutet:
cognitive behavior therapy
child
randomized controlled trial
internet
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders