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临床试验/NCT05598099
NCT05598099招募中不适用

Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

研究概览

简要总结

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

详细描述

The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • fulfills DSM-5 criteria for PTSD
  • One or more single traumas in adolescence or adulthood
  • Speaks and writes Norwegian

排除标准

  • New or unstable psychopharmacological treatment within last four weeks
  • fulfills ICD-11 criteria for complex PTSD
  • Ongoing substance abuse
  • Ongoing danger of suicide
  • Ongoing borderline personality disorder
  • Ongoing psychosis
  • Intellectual disability

结局指标

主要结局

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

时间窗: Change in scores from three months after treatment to twelve months after treatment

Clinician-administered interview to diagnose and the severity of PTSD

次要结局

  • Client Satisfaction Questionnaire 8 (CSQ-8)(Twelve months after treatment)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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