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

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

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).

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11330
    • BUP CPF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-delivered Cognitive-Behavioral Therapy	Behavioral: Internet-delivered Cognitive Behavioral Therapy; The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Children's Global Assessment Scale (C-GAS)	week 0, week 12, at 3 months follow up
Clinical Global Impression - Severity (CGI-S)	week 0, week 12, at 3 months follow up
Clinical Global Impression - Improvement (CGI-I)	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
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)	week 0, week 12, at 3 months follow up and weekly during treatment
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
Autism Spectrum Quotient (AQ-10)	week 0
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)	week 0, week 12, at 3 months follow up
Child Depression Inventory - Short version (CDI-S)	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
Qualitative data on treatment credibility	week 3
Qualitative data on treatment satisfaction	week 12
Safety Monitoring Uniform Report Form (SMURF)	week 6, week 12
Internet Intervention Patient Adherence Scale (iiPAS)	week 6, week 12
Patient Exposure/Response prevention Adherence Scale (PEAS)	week 6, week 12

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: REPN 2015/470-31