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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
University of Rhode Island
Study ID
NCT07217795
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol Use Disorder (AUD)
  • PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CBT + expressive writing — BEHAVIORAL
    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 — BEHAVIORAL
    Participants assigned to the wait-list will not receive active treatment during the study period but will be offered the RISE intervention afterward.

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Sep 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rhode IslandProvidenceRhode Island02860
Jillian Scheer, PhD
[email protected]
401.874.2193

Find similar trials in Providence, RI

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Rhode Island· Providence, RI

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