Obsessive-Compulsive Disorder
Conditions
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.
Interventions
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.
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children´s Yale Brown Compulsive Scale (CY-BOCS) | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Children's Global Assessment Scale (C-GAS) | week 0, week 12, at 3 months follow up |
Countries
Sweden
Outcome results
None listed