Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

Study Overview
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Brief Summary
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The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.

Detailed Description
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The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.

Official Title
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Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Internet-delivered Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a primary diagnosis of OCD as defined by DSM-5 a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS age between 12 and 17 years ability to read and write Swedish daily access to the internet a parent that is able to co-participate in the treatment Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder suicidal ideation ongoing substance dependence subject not able to read or understand the basics of the ICBT material completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention) ongoing psychological treatment for OCD or another anxiety disorder

Ages Eligible for Study
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Minimum Age: 12 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: Internet-delivered CBT<br>Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support. | Behavioral: Internet-delivered Cognitive Behavior Therapy<br>* The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.<br>|
| No Intervention: Wait list<br>Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy. | |

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 from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Severity, CGI-S |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Clinical Global Impression - Improvement, CGI-I |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Parent Adherence EX/RP Scale, PEAS |  | Baseline, 6 and 12 weeks after treatment starts | 
| Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Education, Work and Social Adjustment Scale - child and parent version (EWSAS) |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998 |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Child Depression Inventory - Short version (CDI-S, Kovacs, 1985) |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009) |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| Technology acceptance scale |  | Baseline, 6 and 12 weeks after treatment starts, | 
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P) |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 
| EQ-5D - quality of life |  | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, adolescents, pediatric, internet, online, CBT