iCBT for Children and Adolescents With Obsessive-compulsive Disorder

Study Overview
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Brief Summary
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Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 7 to 17 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data.

Official Title
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Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder

Conditions
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Psychotherapy Intervention Evaluation

Intervention / Treatment
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* Behavioral: Cognitive-bahavioral psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents (ages 7-17) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker German-speaking (child & caretakers) Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone Exclusion Criteria: IQ below 70 A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality that requires acute treatment, and psychosis

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based psychotherapy<br> | Behavioral: Cognitive-bahavioral psychotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL) |  | beginning of the study and end therapy (about 16 weeks) | 
| The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |  | beginning of the study and end therapy (about 16 weeks) | 
| Children's Global Assessment Scale (CGAS) |  | beginning of the study and end therapy (about 16 weeks) | 
| Child Behavior Checklist (CBCL) |  | beginning of the study and end therapy (about 16 weeks) | 
| Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL) |  | beginning of the study and end therapy (about 16 weeks) | 
| Impairment by OCD symptoms | assessed by App | Every day throughout the therapy process (14 weeks) | 
| Extend of avoidance behavior | assessed by App | Every day throughout the therapy process (14 weeks) | 
| Daily mood | assessed by App | Every day throughout the therapy process (14 weeks) | 
| How the day was | assessed by App | Every day throughout the therapy process (14 weeks) | 
| How strong OCD is | assessed by App | Every week throughout the therapy process (14 weeks) | 
| How Every week throughout the therapy processgood e progress was with specific treatment goals | assessed by App | Every week throughout the therapy process (14 weeks) | 
| Anxiety ratings during exposures | assessed by App | Every week three days beginning with session 4 up to 14 | 
| Heart rate variability | assessed with wristband | Every day throughout the therapy (14 weeks) | 
| Skin conductance level | assessed with wristband | Every day throughout the therapy (14 weeks) | 
| Body temperature | assessed with wristband | Every day throughout the therapy (14 weeks) | 
| Body movements | assessed with wristband | Every day throughout the therapy (14 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based