search
Back to results

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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring cognitive behavior therapy, child, randomized controlled trial, internet

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • BUP CPF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICBT

Supportive control

Arm Description

Internet-based cognitive behavior therapy

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.

Outcomes

Primary Outcome Measures

Clinician Severity Rating (CSR)
Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment

Secondary Outcome Measures

Presence of DSM Anxiety disorder
Children´s Globas Assessment Scale (CGAS)
Clinical Global Impression - Improvement (CGI-I)
Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)
Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)
KIDSCREEN-10 Child version
Quality of life
KIDSCREEN-10 Parent version
Quality of life
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Hospital Anxiety and Depression Scale - Parents (HADS)
Technology Acceptance Scale - Child (TAS-C)
Perceived usefulness and perceived ease of use
Technology Acceptance Scale - Parent (TAS-P)
Perceived usefulness and perceived ease of use
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
Measurement of compliance to exposure assignments and anxiety levels, through mobile app
Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app
Unintended treatment effects
Specific Phobia Questionnaire - Child version (SPQ-C)
Specific Phobia Questionnaire - Parent version (SPQ-P)

Full Information

First Posted
January 19, 2015
Last Updated
September 4, 2018
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT02350257
Brief Title
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Official Title
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
cognitive behavior therapy, child, randomized controlled trial, internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICBT
Arm Type
Experimental
Arm Description
Internet-based cognitive behavior therapy
Arm Title
Supportive control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT
Intervention Description
12 weeks of internet-based CBT
Primary Outcome Measure Information:
Title
Clinician Severity Rating (CSR)
Description
Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment
Time Frame
Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary Outcome Measure Information:
Title
Presence of DSM Anxiety disorder
Time Frame
Assessed at Pre, Post, 3-month and 12-month Follow-up
Title
Children´s Globas Assessment Scale (CGAS)
Time Frame
Assessed at Pre, Post, 3-month and 12-month Follow-up
Title
Clinical Global Impression - Improvement (CGI-I)
Time Frame
Assessed at Post, 3-month and 12-month Follow-up
Title
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
Title
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
Title
KIDSCREEN-10 Child version
Description
Quality of life
Time Frame
Assessed at Pre, Post, 3-month and 12-month Follow-up
Title
KIDSCREEN-10 Parent version
Description
Quality of life
Time Frame
Assessed at Pre, Post, 3-month and 12-month Follow-up
Title
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
Title
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
Title
Hospital Anxiety and Depression Scale - Parents (HADS)
Time Frame
Assessed at Pre
Title
Technology Acceptance Scale - Child (TAS-C)
Description
Perceived usefulness and perceived ease of use
Time Frame
Assessed at Mid-3 weeks and Post
Title
Technology Acceptance Scale - Parent (TAS-P)
Description
Perceived usefulness and perceived ease of use
Time Frame
Assessed at Mid-3 weeks and Post
Title
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)
Time Frame
Assessed at Pre, Post, 3-month and 12-month Follow-up
Title
Measurement of compliance to exposure assignments and anxiety levels, through mobile app
Description
Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app
Time Frame
During the 12 weeks of ICBT
Title
Unintended treatment effects
Time Frame
Assessed at Post
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
BUP CPF
City
Stockholm
ZIP/Postal Code
113 30
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30241993
Citation
Jolstedt M, Wahlund T, Lenhard F, Ljotsson B, Mataix-Cols D, Nord M, Ost LG, Hogstrom J, Serlachius E, Vigerland S. Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018 Nov;2(11):792-801. doi: 10.1016/S2352-4642(18)30275-X. Epub 2018 Sep 18.
Results Reference
derived
Links:
URL
http://www.bup.se/bip
Description
Barninternetprojektet

Learn more about this trial

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

We'll reach out to this number within 24 hrs