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临床试验/NCT03595098
NCT03595098进行中(未招募)不适用

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

Anne Katrine Pagsberg2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
128
试验地点
2
主要终点
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the interventions, it is not possible to blind the participants, the investigators administrating the interventions (therapists, i.e. medical doctors and clinical psychologists, and other caregivers), or parents. Blinding will be applied in all possible aspects of the trial such as: outcome assessment and MRI-scanning and neuropsychological testing. Additionally data managers, statisticians, and investigators drawing conclusions, will be fully blinded.

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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 <
  • 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.

结局指标

主要结局

Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score

时间窗: Week 0, 4, 8, 16 and 40

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.

次要结局

  • Occurrence of negative adverse events(Week 4, 8, 16 and 40)
  • health-related quality of life assesses with KIDSCREEN-52(Week 0, 4, 8, 16 and 40)

研究者

发起方
Anne Katrine Pagsberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anne Katrine Pagsberg

Associate professor at Child and Adolescent Mental Health Centre, Copenhagen

Copenhagen Trial Unit, Center for Clinical Intervention Research

研究点 (2)

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