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

Sexual Assault Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111056
• Other study ID #: STUDY00001028
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: May 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrollment at the University of Washington,

• female,

• 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.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Heavy Drinking
• Sexual Assault

Intervention

Behavioral:
• Alc-ERDT
Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Daily Drinking Questionnaire	Assesses typical alcohol consumption over the course of a typical week in the past month	Baseline, Immediately upon completion of the intervention, 1-month and 6-month follow-up