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

Официальное название

Developing a Telehealth Intervention for Alcohol and Trauma Among LGBTQ+ People

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: 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) [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Hazardous drinking levels [Срок оценки: Baseline: Past 3 months 1-week Follow-up: Past 1 week]
• Change in average weekly drinking quantity [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Change in heavy drinking frequency [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]

Вторичные конечные точки (12)

• Depression symptoms [Срок оценки: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Anxiety symptoms [Срок оценки: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Perceived Stress [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Suicidality [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Readiness to change [Срок оценки: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Change in maximum number of drinks on any day [Срок оценки: Baseline: Past 30 days 1-week Follow-up: Past 1 week]
• Alcohol-related consequences [Срок оценки: Baseline: Past 90 days 1-week Follow-up: Past 1 week]
• Alcohol craving [Срок оценки: Baseline: Past 1 week 1-week Follow-up: Past 1 week]
• Alexithymia [Срок оценки: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Anxiety sensitivity [Срок оценки: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Negative emotionality [Срок оценки: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]
• Posttraumatic maladaptive beliefs scale [Срок оценки: Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Rhode Island — Providence

Публикации

• Jaipuriyar V, Behari K, Rashkovsky K, Girard R, Sherman AL, Chasten N, Epshteyn GG, Lee J, Helminen EC, Scheer JR. Brief transdiagnostic cognitive behavioral therapy and expressive writing for hazardous drinking and posttraumatic stress symptoms among sexual and gender minority adults: Pilot trial protocol. Contemp Clin Trials Commun. 2026 Jun 27;52:101666. doi: 10.1016/j.conctc.2026.101666. eColl PMID 42404370

Идентификаторы

NCT: NCT07217795 · 2310793

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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