Alcohol Use, UnspecifiedNCT05646446
Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
A study testing REACH Program in people with Alcohol Use, Unspecified and Sexual Assault, run by Lifespan at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified, Sexual Assault
- What is being tested?
- REACH Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- current suicide risk on the Beck Depression Inventory
- current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02904
About this study
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.
- Conditions
- Alcohol Use, Unspecified, Sexual Assault
- Being tested
- REACH Program
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH ProgramBehavioural
The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.
| Study group | Role | What they receive |
|---|---|---|
| REACH Program | Experimental | The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women. Receives: Behavioral: REACH Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Reductions in comparison to control at 4 months.
Secondary outcomes (3)
Anxiety
Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 4-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start3 Aug 2023
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Why it stopped: Funding Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Orchowski Ph.D., Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646446
- Sponsor's protocol ID
- R34AA030035
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per sponsor requirements, data will be shared using the National Institutes of Mental Health Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
- ClinicalTrials.gov ID
- NCT05646446
- Acronym / sponsor ID
- R34AA030035
- Conditions
- Alcohol Use, Unspecified, Sexual Assault
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding Terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REACH Program | Experimental | Behavioral: REACH ProgramThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- current suicide risk on the Beck Depression Inventory
- current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REACH ProgramThe REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women. | Behavioural | REACH Program |
Primary outcome
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.
3 secondary outcomes
Anxiety
Time frame: Change from baseline at 4-months.
Depression
Time frame: Change from baseline at 4-months.
Mindfulness
Time frame: Change from baseline at 4-months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes. Per sponsor requirements, data will be shared using the National Institutes of Mental Health Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH Program in people with Alcohol Use, Unspecified and Sexual Assault, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: Change from baseline alcohol use at 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.