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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350257
• Other study ID #: BIPSY RCT
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: April 2018

Study information

• Verified date: September 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

Behavioral:
• Internet-based CBT
12 weeks of internet-based CBT

Locations

Country	Name	City	State
Sweden	BUP CPF	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of DSM Anxiety disorder		Assessed at Pre, Post, 3-month and 12-month Follow-up
Secondary	Children´s Globas Assessment Scale (CGAS)		Assessed at Pre, Post, 3-month and 12-month Follow-up
Secondary	Clinical Global Impression - Improvement (CGI-I)		Assessed at Post, 3-month and 12-month Follow-up
Secondary	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
Secondary	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
Secondary	KIDSCREEN-10 Child version	Quality of life	Assessed at Pre, Post, 3-month and 12-month Follow-up
Secondary	KIDSCREEN-10 Parent version	Quality of life	Assessed at Pre, Post, 3-month and 12-month Follow-up
Secondary	Education, Work and Social Adjustment Scale - Child version (EWSAS-C)		Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Secondary	Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)		Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up
Secondary	Hospital Anxiety and Depression Scale - Parents (HADS)		Assessed at Pre
Secondary	Technology Acceptance Scale - Child (TAS-C)	Perceived usefulness and perceived ease of use	Assessed at Mid-3 weeks and Post
Secondary	Technology Acceptance Scale - Parent (TAS-P)	Perceived usefulness and perceived ease of use	Assessed at Mid-3 weeks and Post
Secondary	Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)		Assessed at Pre, Post, 3-month and 12-month Follow-up
Secondary	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	During the 12 weeks of ICBT
Secondary	Unintended treatment effects		Assessed at Post
Secondary	Specific Phobia Questionnaire - Child version (SPQ-C)		Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up
Secondary	Specific Phobia Questionnaire - Parent version (SPQ-P)		Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up

External Links

•   Barninternetprojektet