Recruiting

Virtual Therapy

Sponsor:

University of Rhode Island

Code:

NCT07217795

Conditions

Alcohol Use Disorder (AUD)

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT + expressive writing

Wait-List Control

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder (AUD)

PTSD

Study ID

NCT07217795

Start date

Nov 30, 2025

Status verified date

Dec, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RISE

Description: Participants receive the RISE intervention, a remotely delivered CBT + Expressive Writing program.

Intervention: Behavioral: RISE (CBT + Expressive Writing)

other: Control: Wait-List Control

Participants are placed on a wait-list and offered the RISE intervention after the study period.

Interventions

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-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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jillian Scheer, PhD

401-874-2193jillian.scheer@uri.edu

Locations

University of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02860

Contacts

Jillian Scheer, PhD

401.874.2193jillian.scheer@uri.edu

More Information

Sponsor

University of Rhode Island

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • LGBTQ
  • cognitive behavioral therapy
  • expressive writing
  • PTSD
  • alcohol use
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rhode Island on 2025-12-09.