Internet-delivered CBT for Paediatric OCD

Study Overview
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Brief Summary
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The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).

Detailed Description
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A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD). Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion). The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups. The hypotheses are: An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms. The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment. Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.

Official Title
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Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)
* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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 and 17 years Ability to read and write Swedish and with access to a computer and use of internet. Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial. Exclusion Criteria: Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder. Suicidal ideation Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment. Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention). Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped care<br>Internet-delivered cognitive behavioral therapy (ICBT) | Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)<br>* Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform. Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks.<br>|
| Active Comparator: Gold standard treatment<br>Cognitive behavioral therapy (CBT) | Behavioral: Cognitive behavioral therapy (CBT)<br>* Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention. Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) | Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical global impression severity (CGI-S) | Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up | 
| Clinical global impression improvement (CGI-I) | Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. | week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up | 
| Children's global assessment scale (C-GAS) | Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up | 
| Obsessive-compulsive inventory - child version (OCI-CV) | Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment | 
| The Child Health Utility 9D (CHU9D) | Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up | 
| Insomnia Severity Index (ISI) | Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up | 
| Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R) | Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment | 
| Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR) | Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up | 
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) | Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up. | 
| Mood and Feeling Questionnaire (MFQ) | Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up | 
| Education, work and social adjustment scale (EWSAS) | Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |