About this trial
This is a two-part study to develop and test a brief, virtual therapy program for lesbian, gay, bisexual, transgender, and queer (LGBTQ+) people who have experienced trauma and use alcohol.
Phase 1: You'll be invited to share your perspective to help make the program relevant, inclusive, and affirming.
Phase 2: You may have the opportunity to try the adapted program by receiving free virtual therapy with LGBTQ+-affirming therapists.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
CBT + expressive writing
BehavioralThis study will test a remotely delivered intervention combining Cognitive Behavioral Therapy (CBT) and Expressive Writing (EW) to address unhealthy alcohol use and traumatic stress among sexual minority women (SMW; e.g., lesbian, bisexual women) and transgender and gender-diverse (TGD) individuals. The intervention, called Recovery through Inhibitory Learning, Self-Efficacy Building, Problem-Solving, and Community Building (RISE), integrates CBT modules on assertiveness, problem-solving in high-risk situations, and building social connections with a brief EW program tailored to SMW and TGD participants. Four modules from the Unified Protocol (UP), a transdiagnostic CBT approach, will be adapted: (1) psychoeducation, goal setting, and motivational enhancement; (2) mindful emotional awareness; (3) cognitive flexibility; and (4) countering emotion-driven behaviors.
Wait-List Control
BehavioralParticipants assigned to the wait-list will not receive active treatment during the study period but will be offered the RISE intervention afterward.
Treatment groups
Trial outcomes
Primary outcomes
Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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)
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 levels
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 quantity
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,
Secondary outcomes
Depression symptoms
Title: Depression Severity and Impairment (ODSIS) Description: The Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item self-report measure assessing the frequency and intensity of depressive symptoms, as well as related distress and functional impairment. Each item is rated on a 0-4 scale, with total scores ranging from 0 to 20. Higher scores indicate greater severity of depression and impairment. The ODSIS is sensitive to clinical change and has strong psychometric properties. Units of Measure: Total score (0-20)
Anxiety symptoms
Title: Anxiety Severity and Impairment (OASIS) Description: The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5-item self-report measure assessing the frequency and intensity of anxiety symptoms, as well as related avoidance, distress, and functional impairment. Each item is rated on a 0-4 scale, with total scores ranging from 0 to 20. Higher scores indicate greater anxiety severity and impairment. The OASIS is brief, transdiagnostic, and sensitive to treatment-related change. Units of Measure: Total score (0-20)
Perceived Stress
Title: Perceived Stress (PSS-10) Description: The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure that assesses the degree to which individuals perceive their life situations as stressful over the past month. Each item is rated on a 0-4 scale, with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress. The PSS-10 is widely used and has demonstrated strong reliability and validity across populations. Units of Measure: Total score (0-40)
Suicidality
Title: Suicidal Ideation Attributes Scale (SIDAS) Description: The Suicidal Ideation Attributes Scale (SIDAS) is a 5-item self-report measure assessing the severity of suicidal thoughts over the past 30 days, including frequency, controllability, closeness to attempt, associated distress, and functional interference. Each item is rated on a 0-10 scale, with total scores ranging from 0 to 50. Higher scores indicate more severe suicidal ideation. A score of 21 or above indicates high risk and warrants clinical attention. Units of Measure: Total score (0-50)
Sponsors and contacts
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University of Rhode Island
Lead sponsor
Rhode Island Foundation
Collaborator