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Completed

NCT Number: NCT02350257

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

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.

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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

BUP CPF

Stockholm, 113 30, Sweden

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Internet-based CBT

Behavioral

12 weeks of internet-based CBT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2015
Registry last updated
Sep 6, 2018

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.

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