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

Official title

Developing a Telehealth Intervention for Alcohol and Trauma Among LGBTQ+ People

Overview

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.

Interventions

• Behavioral CBT + expressive writing
  This 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
• Behavioral Wait-List Control
  Participants assigned to the wait-list will not receive active treatment during the study period but will be offered the RISE intervention afterward.

Primary outcome measures

• Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Posttraumatic Stress Disorder Symptom Severity using the PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Hazardous drinking levels [Time frame: Baseline: Past 3 months 1-week Follow-up: Past 1 week]
• Change in average weekly drinking quantity [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Change in heavy drinking frequency [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]

Secondary outcome measures (12)

• Depression symptoms [Time frame: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Anxiety symptoms [Time frame: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Perceived Stress [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Suicidality [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Readiness to change [Time frame: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Change in maximum number of drinks on any day [Time frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Alcohol-related consequences [Time frame: Baseline: Past 90 days 1-week Follow-up: Past 1 week]
• Alcohol craving [Time frame: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Alexithymia [Time frame: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Anxiety sensitivity [Time frame: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Negative emotionality [Time frame: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Posttraumatic maladaptive beliefs scale [Time frame: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]

Eligibility criteria

Aim 1: Sexual Minority Women and Transgender and Gender Diverse Individuals -Not meeting inclusion criteria

Aim 1: Providers

-Not meeting inclusion criteria

Aim 2: Sexual Minority Women and Transgender and Gender Diverse Individuals

• Not meeting inclusion criteria OR any of the following:
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Rhode Island — Providence

Publications

• Jaipuriyar V, Behari K, Rashkovsky K, Girard R, Sherman AL, Chasten N, Epshteyn GG, Lee J, Helminen EC, Scheer JR. Brief transdiagnostic cognitive behavioral therapy and expressive writing for hazardous drinking and posttraumatic stress symptoms among sexual and gender minority adults: Pilot trial protocol. Contemp Clin Trials Commun. 2026 Jun 27;52:101666. doi: 10.1016/j.conctc.2026.101666. eColl PMID 42404370

Identifiers

NCT: NCT07217795 · 2310793

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗