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

University of Rhode Island

Status: Enrolling

Conditions: Alcohol Use Disorder (AUD); PTSD

Treatments: Behavioral: Wait-List Control; Behavioral: CBT + expressive writing

Study type: Interventional

Funder types: Other

Identifiers

NCT07217795

2310793

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

RISE

Experimental group

Description:

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

Treatment:

Behavioral: CBT + expressive writing

Control: Wait-List Control

Other group

Description:

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

Treatment:

Behavioral: Wait-List Control