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Funding Terminated
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH Program | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH Program | Behavioral | The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Depression | Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
Female gender or fluid, gender non-conforming, gender queer, or non-binary
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02904 | United States |
Per sponsor requirements, data will be shared using the National Institutes of Mental Health Data Archive.
The research team will submit data on or before the Data Archive submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of the award.
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| Change from baseline at 4-months. |
| 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. |