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临床试验/NCT01684293
NCT01684293已完成不适用

Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年7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
入组人数
50
试验地点
1
主要终点
Change in cognitive impairment

研究概览

简要总结

This study integrates a model of occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive impairment and quality of life would improve and that cocaine use would decrease in those participants receiving occupational-therapy based cognitive rehabilitation.

详细描述

occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers

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)

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

入选标准

  • Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission
  • At least mild cognitive impairment, defined as = or > 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures
  • Needing to change quality of life, defined as self-identifying at least 2 life areas as needing to change on the Drug User Quality of Life Scale
  • A Veteran at the San Francisco Veterans Affairs Medical Center
  • Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program

排除标准

  • Inability to speak, read, write, and understand English
  • Inadequate hearing or vision
  • Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission
  • A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety)
  • A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score >29
  • Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization
  • Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)
  • Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition
  • Wechsler Test of Adult Reading standard score <70
  • Mini-Mental State Examination score <24
  • Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or other medicines with a high likelihood of sedation & cognitive impairment (e.g., benzodiazepines, clozapine, anticholinergics)
  • Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine)
  • Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice, gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae, such as HIV-related opportunistic infection
  • Any history of any type of stroke or brain hemorrhage
  • Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery
  • Currently on probation or parole
  • Concurrent participation in another study that medically/administratively interferes with this study

研究组 & 干预措施

Psychoeducation/games

Placebo Comparator

Psychoeducation/games

干预措施: Psychoeducation/games (Behavioral)

Cognitive Rehabilitation

Experimental

Occupational therapy-based cognitive rehabilitation

干预措施: Occupational therapy-based cognitive rehabilitation (Behavioral)

结局指标

主要结局

Change in cognitive impairment

时间窗: baseline through 6 months

Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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