NCT03111056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

March 31, 2017

Results QC Date

November 2, 2022

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Daily Drinking Questionnaire

    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

Study Arms (2)

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.

Behavioral: Alc-ERDT

Assessment Only Control

NO INTERVENTION

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

Interventions

Alc-ERDTBEHAVIORAL

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

Web-Based Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified as female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment at the University of Washington,
  • female,
  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Results Point of Contact

Title
Cynthia Stappenbeck
Organization
Georgia State University

Study Officials

  • Cynthia Stappenbeck, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention and assessments are all completed online and therefore masking is not necessary.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 12, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 14, 2026

Results First Posted

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations