Developing a Telehealth Intervention for Alcohol and Trauma Among LGBTQ+ People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Rhode Island
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Posttraumatic Stress Disorder Diagnosis and Severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
RISE
Description: Participants receive the RISE intervention, a remotely delivered CBT + Expressive Writing program.
Intervention: Behavioral: RISE (CBT + Expressive Writing)
Intervention: CBT + expressive writing (Behavioral)
Control: Wait-List Control
Participants are placed on a wait-list and offered the RISE intervention after the study period.
Intervention: Wait-List Control (Behavioral)
Outcomes
Primary Outcomes
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
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)
Posttraumatic Stress Disorder Symptom Severity using the PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week
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).
Hazardous drinking levels
Time Frame: Baseline: Past 3 months 1-week Follow-up: Past 1 week
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
Change in average weekly drinking quantity
Time Frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week
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,
Change in heavy drinking frequency
Time Frame: Baseline: Past 30 days 1-week Follow-up: Past 1 week
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.
Secondary Outcomes
- 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)
- Change in maximum number of drinks on any day(Baseline: Past 30 days 1-week Follow-up: Past 1 week)
- Alcohol-related consequences(Baseline: Past 90 days 1-week Follow-up: Past 1 week)
- Alcohol craving(Baseline: Past 1 week 1-week Follow-up: Past 1 week)
- Alexithymia(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Anxiety sensitivity(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Negative emotionality(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Posttraumatic maladaptive beliefs scale(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Dissociation(Baseline: Past 1-week 1-week Follow-up: Past 1-week)
- Brief experiential avoidance questionarraire(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Coping(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Emotion regulation(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Self-Compassion(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Loneliness(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Social support(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- LGBTQ+ Community connection(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Positive and Negative Affect(Baseline: Past 4 weeks 1-week Follow-up: Past 1 week)
- Physical health(Baseline: Past 2 weeks 1-week Follow-up: Past 1 week)
- LGBTQ-Hypervigilance(Baseline: Past 12 months 1-week Follow-up: Past 1 week)
- Lesbian, Gay, Bisexual Identity Scale(Baseline: At baseline assessment 1-week Follow-up: At 1-week follow-up assessment)
- Cannabis use(Baseline: Past 3 months 1-week Follow-up: Past 1 week)
- Other drug use(Baseline: Past 1 month 1-week Follow-up: Past 1 week)
Investigators
Jillian Scheer
Assistant Professor
University of Rhode Island