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

NCT02350257 | Completed

• 1 other identifier: BIPSY RCT
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

cognitive behavior therapy; child; randomized controlled trial; internet

Outcome Measures

Primary Outcomes (1)

• Clinician Severity Rating (CSR)

  Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment

  Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcomes (17)

• Presence of DSM Anxiety disorder

  Assessed at Pre, Post, 3-month and 12-month Follow-up

• Children´s Globas Assessment Scale (CGAS)

  Assessed at Pre, Post, 3-month and 12-month Follow-up

• Clinical Global Impression - Improvement (CGI-I)

  Assessed at Post, 3-month and 12-month Follow-up

• Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)

  Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up

• Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)

  Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up

Study Arms (2)

ICBT

EXPERIMENTAL

Internet-based cognitive behavior therapy

Behavioral: Internet-based CBT

Supportive control

NO INTERVENTION

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.

Interventions

Internet-based CBT BEHAVIORAL

12 weeks of internet-based CBT

ICBT

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

BUP CPF

Stockholm, 113 30, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30241993 DERIVED

Related Links

• Barninternetprojektet

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, child psychiatrist, MD

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 29, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

SE (1)