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临床试验/NCT02114918
NCT02114918已完成不适用

Attention Training for Childhood Obsessive Compulsive Disorder

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment

研究概览

简要总结

Voluntary and involuntary attention processes are thought to play an important role in the development and maintenance of anxiety disorders including OCD. Individuals with OCD pay greater attention to threat information related to their illness and have difficulty shifting their attention from such triggers. Studies suggest that a change in attention bias may lead to a change in anxiety vulnerability. However, few studies have directly examined the causal role of attention bias in the maintenance of anxiety underlying OCD and whether modification of such biases may reduce pathological anxiety symptoms particularly in children. In this proposal, we aim to translate basic findings from research on cognitive biases in anxiety into a novel computerized intervention for child Obsessive Compulsive Disorder (OCD). The treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective processing of threatening OCD-related information. 52 children with OCD will be randomly assigned to either a 12-session attention modification program (AMP) or an attention control condition (ACC). Clinical assessment of symptom severity along with a brief neurocognitive battery will be conducted before and after treatment. We hypothesize that children in the AMP group at end of treatment will show (1) decreased attention bias to OCD-related triggers using an independent measure of attention bias to assess change and (b) reduced OCD severity. This study is an initial step towards demonstrating the feasibility and efficacy of a novel computerized attention training program for OCD that ultimately may prove to be a highly transportable and accessible intervention for this childhood psychiatric disorder. Furthermore, the project will also examine neurocognitive performance before and after attention training to elucidate possible predictors and mechanisms of treatment response.

详细描述

In this proposal, we aim to translate basic findings from research on cognitive biases in anxiety into a novel computerized intervention for child OCD. The treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective processing of threatening OCD-related information. Briefly, the computerized procedure involves repeatedly redirecting participants' attention away from OCD-relevant threat cues in order to induce selective processing of neutral (non-threat) stimuli. This study is an initial step towards demonstrating the efficacy of a potentially highly transportable and accessible intervention for OCD. Furthermore, the project will also examine neurocognitive performance before and after attention modification to elucidate possible predictors and mechanisms of treatment response.

Aim 1: To examine the preliminary efficacy of a 12-session computerized attention modification program (AMP) on attention bias and symptom severity in children with OCD.

Hypothesis 1a: AMP treatment compared to the attention control condition (ACC) will be associated with a decrease in attention bias towards threat-cues in youth with OCD.

Hypothesis 1b: AMP treatment will be associated with a decrease in OCD symptom severity among OCD youth as measured by clinician-administered diagnostic interview and symptom rating scales.

Aim 2: To examine the changes in neurocognitive status over the course of treatment with AMP in children and adolescents with OCD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Age 8-17 (inclusive) at the time of initial evaluation
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnostic criteria for OCD.
  • Unmedicated or on stable medication treatment for anxiety, OCD, attention deficit hyperactivity disorder, tics, and/or depressive disorder for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
  • Child is fluent English speaker.
  • Parental informed consent and child informed assent must be completed. Parents must agree to their child's participation in this protocol.

排除标准

  • Intelligence Quotient < 80 on Wechsler Abbreviated Scale of Intelligence (WASI).
  • Excessive or problematic substance use as reported per initial telephone screening, or DSM-IV Conduct Disorder within the past 3 months.
  • Subject has a lifetime DSM-IV diagnosis of pervasive developmental disorder, Mania, or Psychotic Disorder.
  • Subject has any serious psychiatric, psychosocial, or neurological condition (i.e., attention deficit hyperactivity disorder, major depressive disorder, anxiety, anxiety, severe aggression, family discord) requiring immediate treatment other than that provided in the current study.

结局指标

主要结局

Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment

时间窗: pre-treatment (week 0) and post-treatment (week 5)

Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales. The CGI-S and CGI-I are clinician-rated scales used in clinical trials for over 25 years. Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.

次要结局

  • Attention Bias Assessment Change from Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))
  • Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))

研究者

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

Susanna Chang, PhD

Assistant Professor

University of California, Los Angeles

研究点 (2)

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