Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial

Karolinska Institutet1 site in 1 country11 target enrollmentJanuary 2016

ConditionsObsessive-Compulsive Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obsessive-Compulsive Disorder
Sponsor: Karolinska Institutet
Enrollment: 11
Locations: 1
Primary Endpoint: Children´s Yale Brown Compulsive Scale (CY-BOCS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Eva Serlachius

MD, PhD

Karolinska Institutet

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Children´s Yale Brown Compulsive Scale (CY-BOCS)

Time Frame: 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 Outcomes

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)