Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Internet-delivered Cognitive Behavioral Therapy

• Registration Number: NCT02663167
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).

Detailed Description

The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-25
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Primary DSM-5 diagnosis of OCD
• Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
• Age between 7-11 years
• Ability to understand Swedish
• Daily access to the Internet
• A parent that can co-participate in the treatment
• Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment

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Exclusion Criteria

• Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
• Suicidal ideation
• Not able to understand the basics of the ICBT self-help material
• Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
• On-going psychological treatment for OCD or another anxiety disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-delivered Cognitive-Behavioral Therapy	Internet-delivered Cognitive Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
Children´s Yale Brown Compulsive Scale (CY-BOCS)	week 0, week 12, at 3 months follow up	Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended

Secondary Outcome Measures

Name	Time	Method
Autism Spectrum Quotient (AQ-10)	week 0
Child Depression Inventory - Short version (CDI-S)	week 0, week 12, at 3 months follow up
Internet Intervention Patient Adherence Scale (iiPAS)	week 6, week 12
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)	week 0, week 12, at 3 months follow up and weekly during treatment
Clinical Global Impression - Improvement (CGI-I)	week 12, at 3 months follow up
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)	week 0, week 12, at 3 months follow up
Mood and Feeling Questionnaire - parent version (MFQ)	week 0, week 12, at 3 months follow up
Clinical Global Impression - Severity (CGI-S)	week 0, week 12, at 3 months follow up
Family Accommodation Scale - Self Rated (FAS-SR)	week 0, week 12, at 3 months follow up
Euroqol - Youth (EQ-5D-Y)	week 0, week 12, at 3 months follow up
Children's Global Assessment Scale (C-GAS)	week 0, week 12, at 3 months follow up
Obsessive-Compulsive Inventory - Child Version (OCI-CV)	week 0, week 12, at 3 months follow up and weekly during treatment
Qualitative data on treatment credibility	week 3
Qualitative data on treatment satisfaction	week 12
Safety Monitoring Uniform Report Form (SMURF)	week 6, week 12
Patient Exposure/Response prevention Adherence Scale (PEAS)	week 6, week 12

Trial Locations

Locations (1)

BUP CPF; 🇸🇪 Stockholm, Sweden