Virtual Therapy for Alcohol Use and Trauma in LGBTQ+ Individuals

This study is testing a virtual therapy program called RISE for sexual minority women (e.g., lesbian, bisexual women) and transgender and gender-diverse individuals who experience both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD). The RISE program combines Cognitive Behavioral Therapy (CBT) and Expressive Writing (EW). You might be assigned to receive the RISE intervention or be on a wait-list and receive the intervention later. The study aims to see if RISE can reduce PTSD symptoms and hazardous drinking levels. We are looking for 80 participants aged 18 and older. This study has two parts: first, you can share your perspective to help develop the program, and then you might try the adapted program with free virtual therapy.

Study design
This is an interventional study with an unclear status, planning to enroll 80 participants. It compares a CBT + expressive writing intervention to a wait-list control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD diagnosis and severity, PTSD symptom severity, and hazardous drinking levels will be measured at baseline and at a 1-week follow-up.

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NCT07217795

Recovery Through Inhibitory Learning, Self-Efficacy Building, Problem Solving, and Community Building

Recruiting
NAAges 18+InterventionalTreatment
University of Rhode Island
~80 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:CBT + expressive writingWait-List Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Measured over Baseline: Past 30 days 1-week Follow-up: Past 1 week
+4 more outcomes measured
Alcohol Use Disorder (AUD)
PTSD
1 sites across 1 states
Rhode Island1

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Eligibility criteria

Inclusion

Reporting current mental health treatment ≥1 day/month
Receiving Cognitive Behavioral Therapy (CBT) in the past 3 months (note: participants are not ineligible if they seek concomitant care after enrollment)
Reporting current alcohol or drug use disorder treatment, except mutual self-help (e.g., Alcoholics Anonymous) or current PTSD/trauma-focused treatment
Need for alcohol detoxification, defined as score ≥15 on the adapted self-report Clinical Institute Withdrawal Assessment for Alcohol - Revised (CIWA-Ar)
Active psychosis, defined as score ≥1 on the psychosis subscale of the Behavior and Symptom Identification Scale - Revised (BASIS-R)
Active mania, defined as score ≥6 on the Altman Self-Rating Mania Scale (ASRM)
Active suicidality, defined as score ≥22 on the Suicidal Ideation Attributes Scale (SIDAS)
Currently legally mandated to attend treatment
  • Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)Baseline: Past 30 days 1-week Follow-up: Past 1 week

    Posttraumatic Stress Disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a clinician-administered interview that evaluates Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) PTSD criteria. It provides both a total severity score (0-80) and a dichotomous diagnosis (present/absent). Units of Measure: Total score (0-80); diagnosis status (yes/no)

  • Posttraumatic Stress Disorder Symptom Severity using the PTSD Checklist for DSM-5 (PCL-5)Baseline: Past 30 days 1-week Follow-up: Past 1 week

    Posttraumatic Stress Disorder (PTSD) symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure. Items are rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Extremely"), with a total score range of 0-80; higher scores indicate greater PTSD symptom severity. A score of 33 or higher suggests probable PTSD. Units of Measure: Total score (0-80).

  • Hazardous drinking levelsBaseline: Past 3 months 1-week Follow-up: Past 1 week

    Structured Clinical Interview for DSM-5 - Substance Use Disorders Module (SCID-5-SUD) Description: Structured Clinical Interview for DSM-5 - Substance Use Disorders Module (SCID-5-SUD) will be used to assess the presence and severity of substance use disorders (SUDs). The SCID-5-SUD is a semi-structured clinical interview administered by trained personnel to determine whether a participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a substance use disorder (e.g., alcohol, cannabis, opioids, stimulants). For each substance, the SCID-5-SUD evaluates 11 diagnostic criteria, including impaired control, social impairment, risky use, and pharmacological indicators. Severity is categorized based on the number of criteria endorsed: mild (2-3), moderate (4-5), or severe (6 or more). Units of Measure: Dichotomous diagnosis status (yes/no); severity level (mild, moderate, severe) if applicable

  • Change in average weekly drinking quantityBaseline: Past 30 days 1-week Follow-up: Past 1 week

    The Timeline Followback (TLFB) method will be used to assess daily alcohol consumption over the past 30 days. Participants report the number of standard drinks consumed each day, using a calendar-assisted structured interview format. Data are used to calculate total number of drinking days, total drinks consumed, average drinks per drinking day, and number of heavy drinking days (4+ drinks for women, 5+ for men). This measure provides a reliable estimate of recent alcohol use patterns and is widely used in clinical and research settings. Units of Measure: Number of drinking days, total drinks, drinks per drinking day,

  • Change in heavy drinking frequencyBaseline: Past 30 days 1-week Follow-up: Past 1 week

    Description: Alcohol use will be assessed using a six-item self-report measure evaluating past-week drinking frequency, quantity, and risky use. Items include: frequency of drinking (scored 0-6), maximum number of drinks in 24 hours (scored 1-10), typical number of drinks per drinking day (scored 1-10), total number of drinks per week (scored 1-11), and frequency of binge drinking (defined as 4 or more drinks in one occasion) and high-intensity drinking (defined as 8 or more drinks in one occasion), both scored 0-6. In addition, the Timeline Followback (TLFB) method will be used to assess daily alcohol use over the past 30 days. The TLFB captures number of drinking days, total number of drinks, average drinks per drinking day, and number of heavy drinking days. Units of Measure: Item scores range 0-6, 1-10, or 1-11; TLFB outcomes include days and number of drinks.