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

NCT ID: NCT07217795

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-09-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RISE

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

Intervention: Behavioral: RISE (CBT + Expressive Writing)

Group Type: EXPERIMENTAL

CBT + expressive writing

Intervention Type: 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.

Control: Wait-List Control

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

Group Type: OTHER

Wait-List Control

Intervention Type: BEHAVIORAL

Participants assigned to the wait-list will not receive active treatment during the study period but will be offered the RISE intervention afterward.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Aim 1: Providers

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Foundation

OTHER

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Jillian Scheer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rhode Island

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jillian Scheer, PhD

Role: CONTACT

jillian.scheer@uri.edu

401-874-2193

Facility Contacts

Jillian Scheer, PhD

Role: primary

jillian.scheer@uri.edu

401.874.2193

Other Identifiers

2310793

Identifier Type: -

Identifier Source: org_study_id