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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02663167
• Date of registration: 21/01/2016
• Prospective Registration: No
• Primary sponsor: Karolinska Institutet
• Public title: Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
• Scientific title: Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
• Date of first enrolment: January 2016
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02663167
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion 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



Age minimum: 7 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obsessive-Compulsive Disorder

Intervention(s)

Behavioral: Internet-delivered Cognitive Behavioral Therapy

Primary Outcome(s)

Children´s Yale Brown Compulsive Scale (CY-BOCS) [Time Frame: week 0, week 12, at 3 months follow up]

Secondary Outcome(s)

Obsessive-Compulsive Inventory - Child Version (OCI-CV) [Time Frame: week 0, week 12, at 3 months follow up and weekly during treatment]

Children's Global Assessment Scale (C-GAS) [Time Frame: week 0, week 12, at 3 months follow up]

Clinical Global Impression - Improvement (CGI-I) [Time Frame: week 12, at 3 months follow up]

Euroqol - Youth (EQ-5D-Y) [Time Frame: week 0, week 12, at 3 months follow up]

Qualitative data on treatment credibility [Time Frame: week 3]

Safety Monitoring Uniform Report Form (SMURF) [Time Frame: week 6, week 12]

Child Depression Inventory - Short version (CDI-S) [Time Frame: week 0, week 12, at 3 months follow up]

Mood and Feeling Questionnaire - parent version (MFQ) [Time Frame: week 0, week 12, at 3 months follow up]

Qualitative data on treatment satisfaction [Time Frame: week 12]

Autism Spectrum Quotient (AQ-10) [Time Frame: week 0]

Family Accommodation Scale - Self Rated (FAS-SR) [Time Frame: week 0, week 12, at 3 months follow up]

Internet Intervention Patient Adherence Scale (iiPAS) [Time Frame: week 6, week 12]

Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P) [Time Frame: week 0, week 12, at 3 months follow up and weekly during treatment]

Clinical Global Impression - Severity (CGI-S) [Time Frame: week 0, week 12, at 3 months follow up]

Education, Work and Social Adjustment Scale - child and parent version (EWSAS) [Time Frame: week 0, week 12, at 3 months follow up]

Patient Exposure/Response prevention Adherence Scale (PEAS) [Time Frame: week 6, week 12]

Secondary ID(s)

REPN 2015/470-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors