LGBTQIA+ Initiative for Empowerment, Support, Coping, and PTSD Education: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:
- Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?
- Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?
- Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms?
- Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?
- Do LGBTQIA+ patients complete these treatments?
Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.
详细描述
This study will compare two PTSD treatments that are known to work: Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT). PTSD treatments have not been tested among LGBTQIA+ people. The study is trying to learn which treatment(s) work the best for LGBTQIA+ people in real world settings. This study will help guide clinical decision-making and the selection of PTSD treatment by health care organizations, clinicians, and patients based on what works best for LGBTQIA+ people.
The study will investigate which treatments work better in reducing PTSD symptoms among LGBTQIA+ people. The study will identify if minority stress (e.g., experiences of stigma and discrimination) and use of drugs or alcohol will moderate the effects of the interventions on PTSD symptoms. This study is investigating if both treatments improve depression symptoms and improve quality of life, and which treatments patients complete. The study is also examining if these treatments are effective for all individuals in the study, and if the effects of treatment are different among: 1) cisgender sexual minority men, cisgender sexual minority women, gender expansive or non-binary individuals, transgender women, transgender men, 2) participants who live in urban versus rural or suburban areas, and 3) racial and ethnic minority LGBTQIA+ participants.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Currently live in California
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •Ability to understand a written informed consent document and the willing to sign it
- •Ability to speak and read English or Spanish
- •Identify as a sexual and/or gender minority
- •Score 33 or higher on the PTSD Checklist-5 (PCL-5)
- •Interest in getting treatment for PTSD
- •Not be in another concurrent psychotherapy treatment (group or individual) for PTSD (psychotherapy treatment for non-PTSD conditions is allowed).
- •Able to attend treatment sessions in person in San Francisco or have access to a device that allows for treatment via videoconferencing.
排除标准
- •Contraindication to any study-related procedure or assessment
- •Clinically significant impairment which interferes with ability to fully participate in the study (including symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, or other disorders)
- •Active suicidal intent
结局指标
主要结局
Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
时间窗: Months 0 (baseline), 3, 6, and 12
The PCL-5 is a validated measure of self-report DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom, with higher scores indicating greater symptom severity.
次要结局
- Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)(Months 3, 6, and 12)
- Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales(Months 0 (baseline), 3, 6, and 12)
- Change in Depression Measured by Patient Health Questionnaire (PHQ-9)(Months 0 (baseline), 3, 6, and 12)
- Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions(Across intervention)
研究者
Annesa Flentje
Professor of Medicine (Stanford Prevention Research Center)
Stanford University