跳至主要内容
临床试验/NCT05599620
NCT05599620
进行中(未招募)
不适用

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Lifespan1 个研究点 分布在 1 个国家目标入组 90 人2023年2月14日

概览

阶段
不适用
干预措施
Control Group
疾病 / 适应症
Alcohol Use, Unspecified
发起方
Lifespan
入组人数
90
试验地点
1
主要终点
Alcohol Use
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 4-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group who will have the opportunity to complete the program after completing the 4-month follow up.

注册库
clinicaltrials.gov
开始日期
2023年2月14日
结束日期
2026年4月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

发起方
Lifespan
责任方
Principal Investigator
主要研究者

Lindsay Orchowski Ph.D.

Professor (Research)

Lifespan

入排标准

入选标准

  • be between the ages of 18 and 24;
  • speak and comprehend English;
  • report a history of attempted or completed penetrative or non-penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation, coercion, or force;
  • report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months;
  • report past year sexual activity;
  • exceed the clinical cut point on the Female Sexual Functioning Index (score of 28.1 or lower) or exceed the cut point for the 13-item Female Sexual Distress Scale-Revised (score of 11 or higher)

排除标准

  • suicide risk on items from the Beck Depression Inventory;
  • screen positive on the Alcohol Use Withdrawal Checklist.

研究组 & 干预措施

Control Group

The comparison is a wait list control group.

AWARE Program

The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.

结局指标

主要结局

Alcohol Use

时间窗: Change from baseline alcohol use at 4 months.

The number of past month drinking days (Minmum = 0, Maximum = 30), average drinks per drinking day (Minmum = 0, Maximum = unspecificed), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes.

Sexual Distress

时间窗: Change from overall levels of sexual dysfunction at 4 months.

Assessed via the Female Sexual Dysfunction Index, Minimum = 2, Maximum = 36 with higher scores meaning worse outcomes, and the Female Sexual Distress Scale, Minimum = 0, Maximum = 52 with lower scores meaning worse outcomes.

Sexual Victimization

时间窗: Reductions in severity and frequency of victimization in comparison to control at 4 months.

Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.

次要结局

  • Sex-Related Drinking Expectancies(Change in sexual related drinking expectancies at 4 months.)

研究点 (1)

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