Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

NCT05646446 — Not applicable, Withdrawn, Lifespan

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05646446
Status	Withdrawn - Funding Terminated
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Sponsor	Lifespan (Other)
Conditions	Alcohol Use, Unspecified, Sexual Assault
Interventions	REACH Program (Behavioral)
Dates	start 2023-08-03, primary completion 2025-03-21, completion 2025-03-21, first posted 2022-12-12, last updated 2025-03-26
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
REACH Program	Experimental	Behavioral: REACH Program	The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women.
Wait List Control Group	No intervention		The Wait List Control Group will have the opportunity to complete the REACH program after completing study assessments at the 4-month follow-up.

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

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 24 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Rhode Island Hospital	Providence, Rhode Island	United States