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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111056
Enrollment
200
Registered
2017-04-12
Start date
2017-01-01
Completion date
2019-01-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Drinking, Sexual Assault

Brief 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.

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.

Interventions

BEHAVIORALAlc-ERDT

Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Daily Drinking QuestionnaireBaseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-upAssesses typical alcohol consumption over the course of a typical week in the past month

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCynthia Stappenbeck, PhD

University of Washington

Baseline characteristics

Characteristic
Age, Continuous20.8 years
STANDARD_DEVIATION 1.6
Daily Drinking Questionnaire (DDQ)14.0 Number of standard drinks per week
STANDARD_DEVIATION 6.4
Difficulties in Emotion Regulation Scale (DERS)93.9 units on a scale
STANDARD_DEVIATION 24.9
Distress Tolerance Scale (DTS)3.0 units on a scale
STANDARD_DEVIATION 0.8
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
90 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Heavy episodic drinking (HED) frequency4.9 Episodes per month
STANDARD_DEVIATION 3.6
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)21.1 units on a scale
STANDARD_DEVIATION 15.7
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
15 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
138 Participants
Region of Enrollment
United States
100 participants
Revised Sexual Experiences Survey (RSES)26.9 units on a scale
STANDARD_DEVIATION 15.2
Sex: Female, Male
Female
100 Participants
Sex: Female, Male
Male
0 Participants
Traumatic Life Events Questionnaire16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 100
other
Total, other adverse events
0 / 1000 / 100
serious
Total, serious adverse events
0 / 1000 / 100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026