跳至主要内容
临床试验/NCT05569915
NCT05569915已完成不适用

Project QueST 2023: Queer Survivors of Trauma

Syracuse University1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
Change in hazardous drinking levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • failing an inclusion criterion

结局指标

主要结局

Change in hazardous drinking levels

时间窗: Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)

The Alcohol Use Disorders Identification Test (AUDIT) will be used to measure hazardous drinking levels. The AUDIT is a 10-item screening measure of problematic alcohol use with individual items ranging from 0 to 4. Scores of 8 and higher are thought to reflect hazardous alcohol use. At baseline and 3-month follow-up assessments, participants will complete the AUDIT in reference to the past month.

Change in drinking quantity

时间窗: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

To assess drinking quantity in the past week, the investigators will ask participants one question that assesses retrospective estimates for number of drinks consumed on average (in a typical week). The investigators will assess change in the total number of drinks consumed on a typical week in the past month from baseline to total number of drinks consumed in the past week at one-week follow-up and from baseline to total number of drinks consumed in a typical week in the past month at 3-months follow-up assessment. At baseline and 3-month follow-up assessments, participants will complete the hazardous drinking quantity question in reference to a typical week during the past month. At the one-week follow-up assessment, participants will complete the hazardous drinking quantity question in reference to the past week.

Change in PTSD symptom severity

时间窗: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

Posttraumatic stress disorder (PTSD) symptoms will be measured with the Psychometric Properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). The PDS-5 is a 24-item self-report measure designed to assess the severity of DSM-5 PTSD symptoms. The 24-item scale comprises a checklist of traumatic event types the individual has experienced, identification of the most distressing traumatic event, and an assessment of PTSD symptoms. The assessment of PTSD symptoms yields a total score and three subscales (re-experiencing, avoidance, and arousal), and a cutoff score of 28 or higher indicates a probable PTSD diagnosis. Items are scored 1 = once a week or less/a little to 4 = 6 or more times a week/severe. At baseline and 3-month follow-up assessments, participants will complete the PDS-5 in reference to the past month. At the one-week follow-up assessment, participants will complete the PDS-5 in reference to the past week.

Change in heavy drinking frequency

时间窗: Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

The investigators will assess the number of heavy drinking days (days where participants assigned female or intersex at birth consume ≥4 standard drinks and participants assigned male at birth consume ≥5 standard drinks). Response options range from 0 = never to 4 = almost every day where higher scores represent greater heavy drinking frequency. The investigators will assess change in frequency of heavy drinking days in the past month from baseline to frequency of heavy drinking days in the past week at one-week follow-up and from baseline to frequency of heavy drinking days in the past month at 3-months follow-up. At baseline and 3-month follow-up assessments, participants will report frequency of heavy drinking days over the past month. At the one-week follow-up assessment, participants will report frequency of heavy drinking days over the past week.

次要结局

  • Change in coping.(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in self-efficacy.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in hope.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in substance use.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in problematic drug use.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in physical health symptoms(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in trauma centrality.(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in sexual minority identity-related experiences(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in perceived stress.(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in depression and anxiety symptoms.(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in heavy drinking presence(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in dissociation(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in emotion regulation.(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in impulsivity.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in attachment style.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in self-compassion.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in suicidality.(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))
  • Change in alexithymia(Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session))
  • Change in general health perceptions(Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jillian Scheer

Assistant Professor, Cobb-Jones Professor Clinical Psychology

Syracuse University

研究点 (1)

Loading locations...

相似试验