Clinical trial NCT05569915: Project QueST 2023: Queer Survivors of Trauma
Official title: Project QueST 2023: Queer Survivors of Trauma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Drinking Heavy
Keywords: sexual trauma
PTSD symptoms
coping
LGBTQ
lesbian
bisexual
Sexual and Gender Minorities
Alcohol-Related Disorders
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: Yale University
name: Massachusetts General Hospital
First posted: 2022-10-06
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the initial efficacy of tailored online writing interventions specifically designed for sexual minority women, transgender individuals, and/or nonbinary people to target the primary outcomes: posttraumatic stress disorder (PTSD) symptom severity and hazardous drinking.

Detailed description: This study aims to provide a novel method for adapting and testing evidence-based expressive writing (EW) treatments for trauma-exposed sexual minority women (SMW) and gender diverse individuals. The investigators will (1) describe the development and components of the proposed EW treatments, (2) discuss our plan for evaluating acceptability and feasibility of the proposed study, (3) identify steps for characterizing preliminary efficacy of EW treatments in reducing PTSD symptom severity and hazardous drinking levels compared to control, and (4) highlight our strategy for preliminarily evaluating mediators and moderators of treatment efficacy.

Eligibility criteria: Inclusion Criteria:

* being at least 18 years of age
* reporting English fluency
* identifying as sexual minority women, inclusive of gender-diverse people
* living in the United States (US)
* reporting one or more Criterion A traumatic events
* having internet and email access
* not having received inpatient psychiatric support in the past six months

Exclusion Criteria:

* failing an inclusion criterion

Primary outcomes:
measure: Change in PTSD symptom severity
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in hazardous drinking levels
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in drinking quantity
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in heavy drinking frequency
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
Secondary outcomes:
measure: Change in trauma centrality.
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in coping.
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in sexual minority identity-related experiences
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in perceived stress.
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in depression and anxiety symptoms.
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in emotion regulation.
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in impulsivity.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in self-efficacy.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in attachment style.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in self-compassion.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in suicidality.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in hope.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in substance use.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in problematic drug use.
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in heavy drinking presence
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in alexithymia
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in dissociation
timeFrame: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)
measure: Change in general health perceptions
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
measure: Change in physical health symptoms
timeFrame: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
affiliation: Syracuse University
name: Jillian R Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
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