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临床试验/NCT01194076
NCT01194076已完成不适用

Wait-list Feasibility Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric OCD

Mayo Clinic3 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
28
试验地点
3
主要终点
Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)

研究概览

简要总结

The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT) delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in children and adolescents. Treatment will consist of exposure and response prevention with an added focus on teaching parents to be exposure coaches.

详细描述

Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do not receive CBT initially due, in part, to the lack of trained providers and geographic barriers (e.g., distance to such providers). Rather, the majority of youth with OCD receive psychiatric medication alone or together with unproven forms of psychotherapy. While some serotonergic medications have demonstrated utility in pediatric OCD, side effects can be common, response rates are modest at best, and symptom remission is rare. Storch et al. have shown that CBT can be delivered effectively in an intensive format over a 3-week time-span; however, even this shortened treatment approach involves considerable time and financial expenditure for those who do not have local access to CBT, including three week's time off from work and the cost of local room and board. Given this, more efficient ways of providing CBT need to be identified and tested to increase the number of people with access to this form of treatment. With this in mind, the proposed feasibility study examines the use of videophone technology to evaluate a 5-day cognitive-behavioral intervention for youth with OCD administered at multiple sites. A total of 30 youth will receive 10 60-75-minute sessions of CBT over 5 days (two sessions a day). Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for administration over a one-week time-span. We will utilize a month-long waitlist control to estimate treatment efficacy. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (i.e., baseline, post-waitlist, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, CBT delivered in a 5-day format would have the potential to help many more families who would otherwise remain untreated or inadequately treated.

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

  • •All patients must meet the following inclusion criteria to be eligible for study participation:
  • •Principal diagnosis of OCD on the ADIS-IV-P and CY-BOCS Total Score ≥ 16
  • •No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry
  • •7 to 17 years old
  • •Availability of at least one parent to accompany the child to all assessment sessions and be present for videophone assessments
  • •Have a computer and high-speed internet within their home
  • •English speaking.

排除标准

  • •Patients will be excluded from the study if they meet any of the following criteria:
  • •History of and/or current psychosis, autism, bipolar disorder, or current suicidality, oppositional defiant disorder, or eating disorder measured by the ADIS-IV-P and all available clinical information
  • •Principal diagnosis other than OCD
  • •Current a positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit their ability to understand CBT (based on clinical interview).
  • •Participants can be included if they are taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic provided that no medication changes were made 8 weeks prior to initiation of CBT or during treatment.

研究组 & 干预措施

5day intensive treatment

Experimental

干预措施: 5-day intensive treatment (Behavioral)

结局指标

主要结局

Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)

时间窗: 1 month before tx, pre-tx, post-tx, 3 month follow-up

The CYBOCS is the gold standard measure of OCD symptoms. The primary outcome is the decrease in CYBOCS scores from pre-tx to post-tx, and post-tx to follow-up, compared to the change from 1 month before tx to pre-tx.

次要结局

  • Spence children's anxiety scale(baseline, pre-tx, post-tx, 3 month follow-up)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Whiteside

PHD

Mayo Clinic

研究点 (3)

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