Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Not Applicable

Withdrawn

• Conditions: Sexual Assault; Alcohol Use, Unspecified
• Interventions: Behavioral: REACH Program

• Registration Number: NCT05646446
• Lead Sponsor: Lifespan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-12
• Study Start: 2023-08-03
• Status Verified: 2025-03
• Primary Completion: 2025-03-21
• Study Completion: 2025-03-21
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REACH Program	REACH Program	The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women.

Primary Outcome Measures

Name	Time	Method
Alcohol Use	Change from baseline alcohol use at 4 months.	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)
Sexual Victimization	Reductions in comparison to control at 4 months.	Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Anxiety	Change from baseline at 4-months.	Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.
Depression	Change from baseline at 4-months.	Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.
Mindfulness	Change from baseline at 4-months.	Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States