- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111056
Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma
May 12, 2026 updated by: Cynthia Stappenbeck, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-Based Intervention
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.
|
Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills
|
|
No Intervention: Assessment Only Control
Participants will be asked to complete only the daily monitoring assessment each morning for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Daily Drinking Questionnaire
Time Frame: Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-up
|
Assesses typical alcohol consumption over the course of a typical week in the past month
|
Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Stappenbeck, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
March 31, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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