Clinical trial NCT02663167: Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
Official title: Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Children´s Yale Brown Compulsive Scale (CY-BOCS)
timeFrame: week 0, week 12, at 3 months follow up
Secondary outcomes:
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: week 0, week 12, at 3 months follow up
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: week 0, week 12, at 3 months follow up
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: week 12, at 3 months follow up
measure: Obsessive-Compulsive Inventory - Child Version (OCI-CV)
timeFrame: week 0, week 12, at 3 months follow up and weekly during treatment
measure: Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)
timeFrame: week 0, week 12, at 3 months follow up and weekly during treatment
measure: Family Accommodation Scale - Self Rated (FAS-SR)
timeFrame: week 0, week 12, at 3 months follow up
measure: Euroqol - Youth (EQ-5D-Y)
timeFrame: week 0, week 12, at 3 months follow up
measure: Autism Spectrum Quotient (AQ-10)
timeFrame: week 0
measure: Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
timeFrame: week 0, week 12, at 3 months follow up
measure: Child Depression Inventory - Short version (CDI-S)
timeFrame: week 0, week 12, at 3 months follow up
measure: Mood and Feeling Questionnaire - parent version (MFQ)
timeFrame: week 0, week 12, at 3 months follow up
measure: Qualitative data on treatment credibility
timeFrame: week 3
measure: Qualitative data on treatment satisfaction
timeFrame: week 12
measure: Safety Monitoring Uniform Report Form (SMURF)
timeFrame: week 6, week 12
measure: Internet Intervention Patient Adherence Scale (iiPAS)
timeFrame: week 6, week 12
measure: Patient Exposure/Response prevention Adherence Scale (PEAS)
timeFrame: week 6, week 12
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP CPF
Study officials:
References: