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临床试验/NCT03111056
NCT03111056已完成不适用

Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma

University of Washington2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1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
200
试验地点
2
主要终点
Changes in Daily Drinking Questionnaire

研究概览

简要总结

The goal of this study is to empirically evaluate a web-based intervention to reduce heavy drinking among college women with a history of sexual assault who display elevated levels of psychological distress. College women with a history of sexual assault often report more heavy drinking and psychological distress than women without a history of assault. Moreover, women with assault histories often have difficulty regulating their emotions and tolerating distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative mood, and poor coping strategies have been associated with poor treatment outcomes and relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation skills with an alcohol intervention may enhance treatment effects among women with a history of sexual assault by decreasing their motivation to drink to cope with depression or anxiety and by building adaptive coping strategies. Therefore, the web-based intervention will include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion regulation and distress tolerance skills from Dialectical Behavior Therapy.

详细描述

For the small randomized controlled trial, heavy drinking college women with a history of sexual assault will be recruited and randomized to receive the intervention or an assessment only control. Online surveys will be administered at baseline, and post-treatment as well as 1-month and 6-months post-treatment.

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
None

盲法说明

The intervention and assessments are all completed online and therefore masking is not necessary.

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

  • Enrollment at the University of Washington,
  • 18 or older,
  • lifetime history of sexual assault (defined as unwanted attempted or completed oral, vaginal, or anal penetration but excluding unwanted sexual contact only),
  • at least 2 instances of heavy episodic drinking (defined as 4 or more drinks in 2 hours) in the past 30 days,
  • average consumption equal or greater than 7 drinks per week in the past 30 days.

排除标准

  • 未提供

研究组 & 干预措施

Web-Based Intervention

Experimental

In an effort to reduce heavy drinking, participants will be asked to complete a daily monitoring assessment each morning for 14 days. Based on their responses, they will be provided a coping skill to either directly address their alcohol use or attempt to improve their emotion regulation and distress tolerance skills.

干预措施: Alc-ERDT (Behavioral)

Assessment Only Control

No Intervention

Participants will be asked to complete only the daily monitoring assessment each morning for 14 days.

结局指标

主要结局

Changes in Daily Drinking Questionnaire

时间窗: Baseline, Immediately upon completion of the intervention, 1-month and 6-month follow-up

Assesses typical alcohol consumption over the course of a typical week in the past month

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

Cynthia Stappenbeck

Assistant Professor

University of Washington

研究点 (2)

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