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

NCT07217795 | Recruiting

• 1 other identifier: 2310793
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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).

  Baseline: Past 30 days 1-week Follow-up: Past 1 week

• 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

  Baseline: Past 3 months 1-week Follow-up: Past 1 week

• 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,

  Baseline: Past 30 days 1-week Follow-up: Past 1 week

• Change in heavy drinking frequency

  Description: Alcohol use will be assessed using a six-item self-report measure evaluating past-week drinking frequency, quantity, and risky use. Items include: frequency of drinking (scored 0-6), maximum number of drinks in 24 hours (scored 1-10), typical number of drinks per drinking day (scored 1-10), total number of drinks per week (scored 1-11), and frequency of binge drinking (defined as 4 or more drinks in one occasion) and high-intensity drinking (defined as 8 or more drinks in one occasion), both scored 0-6. In addition, the Timeline Followback (TLFB) method will be used to assess daily alcohol use over the past 30 days. The TLFB captures number of drinking days, total number of drinks, average drinks per drinking day, and number of heavy drinking days. Units of Measure: Item scores range 0-6, 1-10, or 1-11; TLFB outcomes include days and number of drinks.

  Baseline: Past 30 days 1-week Follow-up: Past 1 week

Secondary Outcomes (26)

• Depression symptoms

  Baseline: Past 1 week 1-week Follow-up: Past 1 week

• Anxiety symptoms

  Baseline: Past 1 week 1-week Follow-up: Past 1 week

• Perceived Stress

  Baseline: Past 30 days 1-week Follow-up: Past 1 week

• Suicidality

  Baseline: Past 30 days 1-week Follow-up: Past 1 week

• Readiness to change

  Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment

Study Arms (2)

RISE

EXPERIMENTAL

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

Behavioral: CBT + expressive writing

Control: Wait-List Control

OTHER

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

Behavioral: Wait-List Control

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.

RISE

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.

Control: Wait-List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Rhode Island: lead
• Rhode Island Foundation: collaborator

Study Sites (1)

University of Rhode Island

Providence, Rhode Island, 02860, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Drinking Behavior; Behavior

Central Study Contacts

Jillian Scheer, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The overall objective of this project is to adapt and pilot test a remotely delivered alcohol-focused cognitive behavioral therapy (CBT) intervention and trauma-focused expressive writing (EW) intervention addressing social determinants of unhealthy alcohol use and traumatic stress among sexual minority women (SMW; e.g., lesbian, bisexual) and transgender and gender-diverse (TGD) people. The Recovery through Inhibitory Learning, Self-Efficacy Building, Problem-Solving, and Community Building (RISE) intervention will integrate adapted CBT modules on assertiveness, problem-solving in high-risk situations, and connecting with others-shown to reduce unhealthy alcohol use-with a brief EW intervention tailored to SMW and TGD people. The four specific Unified Protocol (CBT) modules that will be adapted for the current study are 1) Psychoeducation, goal setting, motivational enhancement; 2) Mindful emotional awareness; 3) Cognitive flexibility; and 4) Countering emotional-driven behaviors.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: October 16, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)