Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Co… (NCT03595098) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder
Denmark128 participantsStarted 2018-08-28
Plain-language summary
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.
Who can participate
Age range8 Years – 17 Years
SexALL
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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.
What they're measuring
1
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score