跳至主要内容
临床试验/NCT04852770
NCT04852770终止不适用

A Randomized Clinical Trial to Assess the Efficacy of Online Treatment With Trial-based Cognitive Therapy, Mindfulness-based Health Promotion and Positive Psychotherapy for Post-traumatic Stress Disorder During the Covid-19 Pandemics

Fundação Bahiana de Infectologia6 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
135
试验地点
6
主要终点
The Clinician-Administered PTSD Scale (CAPS-5)

研究概览

简要总结

The psychotherapies to be assessed in the present study, delivered on-line, are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT). Objectives: 1) to assess the efficacy of TBCT compared to MBHP and PPT in reducing the symptoms of PTSD during the COVID-19 pandemic.

详细描述

Background: Research has suggested the use of different forms of psychotherapy to decrease drop-out rates in the post-traumatic stress disorder (PTSD) treatment. The psychotherapies to be assessed in the present study are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP) and Positive psychotherapy (PPT). Objectives: Our objectives are: 1) to assess the efficacy of TBCT compared to MBHP and PPT to reduce the symptoms of PTSD in the context of the COVID-19 pandemic, all delivered online; 2) to compare the efficacy of these psychotherapies in reducing symptoms of anxiety and depression, and in improving well-being; 3) to describe how patients and professionals perceive teletherapy. Methods: This is a three-arm, randomized, multicenter, single-blind, clinical trial. An estimated sample of 135 patients will receive either TBCT, MBHP or PPT, individual, weekly visits, totaling thirteen sessions. The primary outcome measure will be the CAPS-5, and the secondary outcome measures will be the Hospital Anxiety and Depression Scale (HADS), the Negative Core Beliefs Inventory (NCBI), and the Trauma-Related Guilt Inventory (TRGI). Other measures are the WHO-5 Well-being Index (WHO-5), and the California Psychotherapy Alliance Scale (CALPAS-P). Also, questions about patients perception of teletherapy will be asked. Expected results: PTSD symptoms are expected to be reduced after TBCT, MBHP and PPT. The null hypothesis is that no statistical difference is expected to be found among the three psychotherapies, as opposed to the alternative hypothesis that TBCT and MBHP are superior to PPT.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • both sexes;
  • aged 18 to 60 years;
  • scoring 45 or more on the PCL-5
  • PTSD developed (or aggravated by) as a result of direct or indirect exposure to COVID-19 [e.g., health professionals, people who tested positive for Covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves];
  • Participants should be able to read, write and follow instructions, and have access to the a stable internet connexion.

排除标准

  • severe suicide risk (plans, attitudes or suicide attemps for the last 12 months);
  • self-mutilation behavior (for the last 12 months);
  • already in psychotherapy;
  • psychotic symptoms;
  • current substance abuse or addiction (last 12 months).

结局指标

主要结局

The Clinician-Administered PTSD Scale (CAPS-5)

时间窗: Baseline and week 14.

It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)

次要结局

  • Hospital Anxiety and Depression Scale (HADS)(From baseline to post-treatment, up 14 weeks.)
  • Trauma-Related Guilt Inventory (TRGI)(Baseline and week 14.)
  • Negative Core Beliefs Inventory (NCBI)(Baseline and week 14.)
  • The World Health Organization Five Well-being index (WHO-5)(Baseline and week 14.)
  • California Psychotherapy Alliance Scale - Patient version (CALPAS-P)(From baseline to post-treatment, up to 14 weeks.)

研究者

发起方
Fundação Bahiana de Infectologia
申办方类型
Other
责任方
Sponsor

研究点 (6)

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