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临床试验/NCT03855943
NCT03855943Unknown不适用

Personalized Computerized Inhibitory Control Training for OCD

Hebrew University of Jerusalem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月11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
100
试验地点
1
主要终点
Obsessive-compulsive symptoms measured after 3 weeks of treatment

研究概览

简要总结

This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

详细描述

This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Principal diagnosis of OCD (assessed by SCID).
  • •Clinically significant OCD symptoms (Y-BOCS score of at least 14).
  • •Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
  • •Have access to a computer or laptop.

排除标准

  • •Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
  • •Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
  • •Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
  • •Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
  • •Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
  • •Active suicidality warranting immediate clinical care.

研究组 & 干预措施

CBT + Personalized Computer Program

Experimental

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program

干预措施: Personalized Computer Program (Behavioral)

CBT + Personalized Computer Program

Experimental

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program

干预措施: CBT (Behavioral)

结局指标

主要结局

Obsessive-compulsive symptoms measured after 3 weeks of treatment

时间窗: 3 weeks

Measured by Yale-Brown Obsessive Compulsive Scale (YBOCS), considered the gold standard assessment tool. Y-BOCS comprises a Symptom Checklist and Severity Scale to consecutively rate obsessions and compulsions. The Checklist includes 54 common obsessions and compulsive behaviors, which are grouped according to thematic content. Symptoms that are endorsed over the past week are then globally rated by the clinician using a five-point scale ranging from 0 (none) to 4 (extreme) across five dimensions: (1) time/frequency, (2) interference, (3) distress, (4) resistance, and (5) degree of control. Obsessive and compulsive symptom severity are rated separately (scores range from 0 to 25) with these scores summed to create a total OCD severity score (range, 0-50). Symptom severity scores: mild symptoms (0-13), moderate symptoms (14-25), moderate-severe symptoms (26-34), and severe symptoms (35-40).26

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

Noa Tauber

Research Assistant

Hebrew University of Jerusalem

研究点 (1)

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