Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Alcohol Use, Unspecified Clinical Trial

Official title:

Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646446
• Other study ID #: R34AA030035
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Lifespan
• Contact: Lindsay Orchowski, PhD
• Phone: 4014447021
• Email: lindsay_orchowski[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address reducing alcohol use, sexual revictimization, and psychological distress among bisexual+ women (i.e., attraction to more than one gender: bisexual, pansexual, queer). The main questions the study seeks to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relative to control, at the 2- and 4-month follow-up period, produce reductions in the quantity and frequency of alcohol use, sexual victimization, and psychological distress (anxiety, depression). Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• be between the ages of 18 and 24 years of age;

• identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary

• identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer);

• report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, incapacitation or force;

• report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;

• report past month sexual activity.

Exclusion Criteria:

• current suicide risk on the Beck Depression Inventory

• current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Sexual Assault

Intervention

Behavioral:
• REACH Program
The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use	The number of past month drinking days (Minimum = 0, Maximum = 31), average drinks per drinking day (Minimum = 0, Maximum = unspecified), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes)	Change from baseline alcohol use at 4 months.
Primary	Sexual Victimization	Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.	Reductions in comparison to control at 4 months.
Secondary	Anxiety	Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.	Change from baseline at 4-months.
Secondary	Depression	Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.	Change from baseline at 4-months.
Secondary	Mindfulness	Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.	Change from baseline at 4-months.