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临床试验/NCT02973932
NCT02973932Unknown不适用

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

University Hospital Tuebingen0 个研究点目标入组 20 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Child Behavior Checklist (CBCL)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Internet-based psychotherapy

Experimental

干预措施: Cognitive-bahavioral psychotherapy (Behavioral)

结局指标

主要结局

Child Behavior Checklist (CBCL)

时间窗: beginning of the study and end therapy (about 16 weeks)

How the day was

时间窗: Every day throughout the therapy process (14 weeks)

assessed by App

Heart rate variability

时间窗: Every day throughout the therapy (14 weeks)

assessed with wristband

Body movements

时间窗: Every day throughout the therapy (14 weeks)

assessed with wristband

Impairment by OCD symptoms

时间窗: Every day throughout the therapy process (14 weeks)

assessed by App

Body temperature

时间窗: Every day throughout the therapy (14 weeks)

assessed with wristband

The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)

时间窗: beginning of the study and end therapy (about 16 weeks)

The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

时间窗: beginning of the study and end therapy (about 16 weeks)

Extend of avoidance behavior

时间窗: Every day throughout the therapy process (14 weeks)

assessed by App

How Every week throughout the therapy processgood e progress was with specific treatment goals

时间窗: Every week throughout the therapy process (14 weeks)

assessed by App

Anxiety ratings during exposures

时间窗: Every week three days beginning with session 4 up to 14

assessed by App

Children's Global Assessment Scale (CGAS)

时间窗: beginning of the study and end therapy (about 16 weeks)

Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)

时间窗: beginning of the study and end therapy (about 16 weeks)

Daily mood

时间窗: Every day throughout the therapy process (14 weeks)

assessed by App

How strong OCD is

时间窗: Every week throughout the therapy process (14 weeks)

assessed by App

Skin conductance level

时间窗: Every day throughout the therapy (14 weeks)

assessed with wristband

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. Annette Conzelmann

PD Dr. Annette Conzelmann

University Hospital Tuebingen

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