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临床试验/NCT03883646
NCT03883646已完成不适用

Mindfulness for Alcohol Abusing Offenders

The Mind Research Network2 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2018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
392
试验地点
2
主要终点
Change from baseline daily alcohol consumption

研究概览

简要总结

Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Thus, there is a critical need for more effective interventions that could help disrupt this insidious cycle of alcohol abuse, criminal behavior, and incarceration. This project will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.

详细描述

The pernicious link between substance abuse and criminal behavior imposes major costs to society, totaling billions of dollars in the U.S. annually. There is a critical need for more effective interventions to counteract the high rates of relapse and recidivism in alcohol and substance abusing criminal offenders. Periods of offender incarceration provide a unique opportunity to develop and deploy such interventions. Progress in intervention development could be achieved by targeting specific cognitive and affective vulnerabilities that are common among substance abusing criminal offenders. Preliminary studies suggest that meditative or mindfulness interventions may confer significant psychological and behavioral benefits to inmates. However, the mechanisms and extent of intervention efficacy are unclear, as these previous studies have been beset by a number of methodological limitations. Moreover, to date no study has examined the neurobiological mechanisms that relate to treatment success in this population. NIAAA has recently made a program call to address these issues (PA-15-299). Here we answer this program call and propose to undertake a rigorous and comprehensive longitudinal study of mindfulness treatment of alcohol and substance use disorders among female inmates. This project will randomly assign over 400 female inmates to a mindfulness or relapse prevention training course, and both will be compared against a no treatment control. The mindfulness intervention will be tailored to address two key neuropsychological deficits in alcohol abusing criminal offenders: impulsivity and craving. We will test hypotheses about the neural changes over time with treatment to elucidate mechanisms of change. We will obtain estimates of "real-world" efficacy of the intervention by collecting outcome measures in prison (conduct reports) and following release (alcohol use relapse and antisocial behavior). This project takes advantage of a unique, longstanding partnership between the research team and the states of New Mexico and Wisconsin Correction Departments that allows collection of comprehensive assessment data from inmates during incarceration, including brain imaging data with a mobile MRI scanner, as well as access to post-release outcomes and relapse data. Completion of these aims is a critical step for implementing and evaluating a promising mindfulness intervention for this high-risk population. The proposed research will also begin to elucidate the psychological and neurobiological mechanisms of the treatment. These results will thus significantly advance a program of research seeking to translate the growing knowledge of neuropsychological deficits into more targeted and effective treatments for alcohol and substance abuse problems in criminal offenders.

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
Female
接受健康志愿者

入选标准

  • 18-65 years of age
  • Alcohol Use Disorder
  • Female (biological sex at birth)
  • Time to release from incarceration > 3 months
  • 5th grade or higher reading level
  • Able to speak and understand English

排除标准

  • Uncorrectable auditory or visual deficits
  • Intelligence Quotient score below 70
  • History of dementia or other cognitive disability
  • Current psychotic disorder (chronic schizophrenia or schizoaffective disorder and/or active psychotic symptoms)
  • Major medical illness or Central Nervous System disease
  • MRI incompatibility (e.g., metal in body)

研究组 & 干预措施

Mindfulness

Experimental

Mindfulness

干预措施: Mindfulness (Behavioral)

Relapse Prevention

Experimental

干预措施: Relapse Prevention (Behavioral)

Waitlist Control

No Intervention

Treatment as Usual

No Intervention

结局指标

主要结局

Change from baseline daily alcohol consumption

时间窗: Every 3 months after release from incarceration

Timeline Follow Back

Change from baseline temptation to drink alcohol

时间窗: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)

Abstinence Self-Efficacy Scale. 40-item, self-report measure assessing how tempted the participant found themselves to drink under various circumstances. Total score range 0-160. Higher scores indicate higher temptation to drink.

Criminal Behavior

时间窗: An average of six months after release from incarceration

Crime Inventory

Change from baseline alcohol craving

时间窗: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)

Penn Alcohol Craving Scale. 5-item, self-report measure assessing frequency, intensity, and duration of craving, and overall rating of craving for the previous week. Total score range 0-30. Higher scores indicate higher craving.

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

Kent Kiehl

Professor of Psychology, Neuroscience and Law, Executive Science Officer

The Mind Research Network

研究点 (2)

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