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临床试验/NCT01413984
NCT01413984已完成不适用

Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study

University of Tulsa2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
2
主要终点
PTSD checklist (change from baseline at one week post treatment)

研究概览

简要总结

The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below:

  1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group.
  2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Incarcerated women at Eddie Warrior Correctional Center (EWCC) in Taft, Oklahoma
  • The following 6 criteria are then employed at EWCC for HWR/BT treatment eligibility:
  • An Level of Service Inventory (LSI) score of 30 or greater
  • An LSI protective score of 15 or less
  • 1.5 years or less remaining in prison
  • A Case Plan identifying substance abuse treatment need
  • Ability to read and comprehend
  • 18 years of age or older

排除标准

  • Under age 18
  • Not incarcerated
  • More than 1.5 years remaining in prison
  • LSI score less than 30 or a protective of more than 15
  • No identified substance abuse need
  • Inability to read and comprehend

结局指标

主要结局

PTSD checklist (change from baseline at one week post treatment)

时间窗: one-week before treatment, one week post treatment

17 item post traumatic stress disorder symptoms checklist will be administered pre treatment and one week following 4 month treatment completion.

Trauma Related Nightmare Survey (change from baseline at one week post treatment)

时间窗: one week before treatment, one week post treatment

brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.

Posttraumatic Cognitions Inventory (change from baseline at one week post treatment)

时间窗: one week before treatment, one week post treatment

36 item assesment of cognitions related to world, self and blame to be administered pre-treatment and one week following 4 month treatment completion.

CES-D, NIMH (change from baseline at one week post treatment)

时间窗: one week before treatment, one week post treatment

Center for Epidemiologic Studies Depression Scale (CES-D), NIMH is a 20 item depression inventory to be administered pre-treatment and one week following 4 month treatment completion.

Drug-Taking Confidence Questionnaire (change from baseline at one week post treatment)

时间窗: one week before treatment, one week post treatment

50 item assessment of alcohol and drugs self efficacy to be administered pre-treatment and one week following 4 month treatment completion.

Trauma Symptoms Inventory (change from baseline at one week post treatment)

时间窗: one week before treatment, one week post treatment

100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.

次要结局

  • Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment)(one week before treatment, one week post treatment)

研究者

发起方
University of Tulsa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachael Swopes

Graduate Student

University of Tulsa

研究点 (2)

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