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Clinical Trials/NCT05646446
NCT05646446
Withdrawn
N/A

Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Lifespan1 site in 1 country90 target enrollmentAugust 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Use, Unspecified
Sponsor
Lifespan
Enrollment
90
Locations
1
Primary Endpoint
Alcohol Use
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2023
End Date
March 21, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lifespan
Responsible Party
Principal Investigator
Principal Investigator

Lindsay Orchowski Ph.D.

Associate Professor (Research)

Lifespan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Alcohol Use

Time Frame: 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

Time Frame: 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.)
  • Depression(Change from baseline at 4-months.)
  • Mindfulness(Change from baseline at 4-months.)

Study Sites (1)

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