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

NCT ID: NCT03111056

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Sexual Assault; Heavy Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alc-ERDT

Intervention Type: BEHAVIORAL

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

Assessment Only Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alc-ERDT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Stappenbeck

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Stappenbeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00001028

Identifier Type: -

Identifier Source: org_study_id