Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
1 other identifier
interventional
11
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 28, 2016
November 1, 2016
9 months
January 21, 2016
November 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (1)
Internet-delivered Cognitive-Behavioral Therapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BUP CPF
Stockholm, 11330, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 21, 2016
First Posted
January 26, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 28, 2016
Record last verified: 2016-11