Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

Detailed Description
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Obsessive-compulsive disorder is the fourth most common psychiatric disorder, affecting 1-3% of children and adolescents globally. The recommended first-line treatment is cognitive behavioral therapy with exposure and response prevention. Yet, more than 40% of patients do not, or only partially, benefit from therapy. A better understanding of the mechanisms underlying response to cognitive behavioral therapy is needed to improve treatment. In the TECTO study, we will conduct a combined randomized clinical trial and longitudinal case-control study to elucidate how neural, cognitive, emotional, and neuroendocrine factors moderate and mediate treatment response. At baseline, 128 children and adolescents with obsessive-compulsive disorder will be compared to 128 healthy control participants to map neurobiological, cognitive, and emotional markers of obsessive-compulsive disorder. After baseline assessment, patients are randomly assigned to 16 weeks of either cognitive behavioral therapy with exposure and response prevention or an active control treatment with psychoeducation and relaxation training. This design allows us to test how factors that are specific to cognitive behavioral therapy (e.g. exposure and response prevention) contribute to observed treatment effects. Our primary outcome is OCD symptom severity measured with the Children's Yale-Brown Obessive-Compulsive Scale. Secondary outcomes are health-related quality of life and negative treatment effects. To detect neural and cognitive mediators of treatment, we will measure brain structure and function, and cognitive performance, at baseline and end-of-treatment. Furthermore, we will monitor a range of therapeutic, emotional, family, and neuroendocrine factors before, during, and after treatment. We expect that findings from TECTO will have important theoretical implications and will help refine our understanding of OCD as a heterogeneous and multidimensional disorder. Finally, we expect that our findings will contribute significantly to the improvement of psychotherapy and development of more targeted interventions for pediatric obsessive-compulsive disorder, which can minimize the use of medication, prevent chronicity, and reduce the substantial socioeconomic burden of the disorder.

Official Title
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Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence

Intervention / Treatment
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* Behavioral: Family Based Cognitive Behavioural Therapy
* Behavioral: Family Based Psychoeducation/Relaxation Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OCD diagnosis as primary diagnosis, meeting the criteria for International Classification of Diseases 10 (ICD-10) F42, verified with a semi-structured psychopathological interview using Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL). Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥16, a cut-off score used in previous studies. Age 8 through 17 years (both inclusive). Signed informed consent. Exclusion Criteria: Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2). Intelligence Quotient <70. Treatment with Cognitive Behavioural Therapy (CBT), Serotonin Reuptake Inhibitors, or other antidepressant medication or antipsychotic medication within the last 6 months prior to trial entry. For MRI-scanning: metal braces on teeth or metal implants; any known brain pathology; history of severe head-trauma (ICD-10 S6-S9); pregnancy.

Ages Eligible for Study
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Minimum Age: 8 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
Interventional Model Description: single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCBT<br>The Family Based Cognitive Behavioural Therapy (FCBT) | Behavioral: Family Based Cognitive Behavioural Therapy<br>* Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.<br>|
| Active Comparator: FPRT<br>Family-based Psychoeducation /Relaxation Training (FPRT) | Behavioral: Family Based Psychoeducation/Relaxation Training<br>* Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score | Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. | Week 0, 4, 8, 16 and 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life assesses with KIDSCREEN-52 | The KIDSCREEN instruments assess children's and adolescents' subjective health and well-being- health-related quality of life (HRQoL). Questionnaire consisted of 52 items which assessed HRQoL in 10 dimensions: physical well-being, psychological well-being, moods and emotions, self perception, autonomy, relation with parents and home life, social support and peers, school environment, social acceptance, and financial resources. Rasch scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10; higher scores indicate better HRQoL and well-being. | Week 0, 4, 8, 16 and 40 | 
| Occurrence of negative adverse events | The occurrence of negative adverse events is assessed with the Negative Effects Questionnaire (NEQ). The questionnaire is used for both parental reports and self-reports. It consists of 32 items that are scored on a five-point Likert-scale (0-4) where the highest value represents a severe negative effect of the event. The questionnaire differentiates between negative effects that are attributed to the treatment and those possibly caused by other circumstances, as well as one open-ended question. | Week 4, 8, 16 and 40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD