跳至主要内容
临床试验/NCT04532996
NCT04532996已完成不适用

Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年8月12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
12
试验地点
1
主要终点
Change in Treatment Response on Clinician Administered PTSD Scale for DSM-5

研究概览

简要总结

This is a pilot, open trial of trauma-focused psychodynamic psychotherapy for LGBT-identifying individuals who meet for DSM-5 defined post-traumatic stress disorder and are interested in receiving a research psychotherapy intervention. A sample of at least 15 therapy completers will be collected.

详细描述

Despite high prevalence of PTSD among LGBT individuals, there are no data characterizing the disorder in this population, nor its treatment. This represents an important under-researched area in LGBT care and treatment. The purpose of this study is: (a) to preliminarily characterize PTSD within an LGBT sample; and (b) to test out the preliminary effects and acceptability of a novel PTSD psychotherapy, trauma-focused psychodynamic psychotherapy, in this group. Participants identifying as LGBT and meeting DSM-5 criteria for PTSD per a structured, reliable clinical interview for PTSD will receive 20-24 sessions of twice-weekly TFPP at no cost. Participants will receive four detailed clinical research assessments, at baseline/study entry, Week 5 of treatment, treatment termination/end (Week 12), and 3-months after the end of treatment.

TFPP is adapted from the only empirically supported, non-exposure focused psychodynamic therapy for panic disorder and anxiety disorders, panic-focused psychodynamic psychotherapy. TFPP aims to improve patients' ability to understand and manage strong, intense emotions that appear seemingly "out of the blue," which links to their tendency to reexperience traumatic events in the here-and-now. TFPP addresses the psychological meanings of symptoms and their relationship to traumatic events to help the patient understand underlying emotions triggering their symptoms and the ways in which trauma influences their current experiences. TFPP was developed for patients with complex PTSD, who often have multiple prior trauma exposures with no clear "index" trauma. Moreover, TFPP also explicitly considers opportunities for patients to explore the broader context of their symptoms and difficulties, including but not limited to LGBT identity or experiences of oppression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identify as LGBTQ
  • CAPS-5 diagnosed PTSD per DSM-5 criteria
  • Stable medication for >=2 months and ongoing during treatment

排除标准

  • Psychosis or bipolar disorder
  • Primary substance use disorder
  • Severe suicidality
  • Severe depression per a reconstructed Hamilton Rating Scale for Depression score of >=24
  • Organic mental syndromes interfering with trial demands

结局指标

主要结局

Change in Treatment Response on Clinician Administered PTSD Scale for DSM-5

时间窗: Baseline (to calculate what is defined as a 30% change from initial CAPS severity score), Mid-Treatment (Week 5), Termination (Week 12), Follow-Up (3 Months Post Treatment)

The CAPS is the gold-standard measure for PTSD symptoms and diagnosis given by trained research assistants; lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS.

次要结局

  • Attrition from treatment by end of therapy duration (Week 12)(Anytime between Baseline and Termination (Week 12))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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