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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT03111056

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Assault Heavy Drinking	Behavioral: Alc-ERDT	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

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.	Behavioral: Alc-ERDT 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.

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.

Behavioral: Alc-ERDT

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.

Outcome Measures

Primary Outcome Measures

Changes in Daily Drinking Questionnaire [Baseline, Immediately upon completion of the intervention, 1-month and 6-month follow-up]
Assesses typical alcohol consumption over the course of a typical week in the past month

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98105

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator: Cynthia Stappenbeck, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cynthia Stappenbeck, Assistant Professor, University of Washington

ClinicalTrials.gov Identifier:

NCT03111056

Other Study ID Numbers:

STUDY00001028

First Posted:

Apr 12, 2017

Last Update Posted:

May 7, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sexual Trauma

Study Results

No Results Posted as of May 7, 2019