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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646446
Other study ID # R34AA030035
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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