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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Recovery Through Inhibitory Learning, Self-Efficacy Building, Problem Solving, and Community Building
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- 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.