跳至主要内容
临床试验/NCT04631887
NCT04631887已完成不适用

The Feasibility Study of The Delivery of The Book From Self Help Plus: "Doing What Matters in Times of Stress: An Illustrated Guide"

Koç University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Change of the Patient Health Questionnaire-9 (PHQ-9) over time

研究概览

简要总结

The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. The informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 Turkish and 64 Syrian) participants who meet the inclusion criteria will be included in the feasibility study. The psychological problems will be measured twice, before and after the intervention.

详细描述

Studies about the impact of epidemics such as Severe acute respiratory syndrome (SARS) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. Today, studies on the effects of COVID-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics.

The aim of this project is to deliver the "Doing What Matters in Times of Stress: An Illustrated Guide" that is developed by the World Health Organization within Self Help Plus (SH+) intervention to decrease their psychological problems for a feasibility study. The feasibility study for the delivery of the SH+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results.

The most important contribution of the Project is conducting a feasibility study with the "Doing What Matters in Times of Stress: An Illustrated Guide" which will be adapted to the Turkish culture based on the determination of Turkey's current psychological status, provide a form of intervention to the Turkish psychological intervention literature and to improve the psychological status of the participants in this project.

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
None

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 18 years or above
  • Being literate
  • Being a Turkish citizen or a Syrian refugee
  • Scoring 15 or above on Kessler Psychological Distress Scale (K10)

排除标准

  • Imminent suicidal risk
  • Being illiterate

结局指标

主要结局

Change of the Patient Health Questionnaire-9 (PHQ-9) over time

时间窗: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)

Patient Health Questionnaire-9 is a 9 item questionnaire that aims to measure the severity of depression symptoms. Each of the 9 items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate decreased functional status and increased symptom-related difficulties.

次要结局

  • Change of the General Anxiety Disorder-7 (GAD-7) over time(Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment))
  • Change of the The Acceptance and Action Questionnaire (AAQ-2) over time(Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment))
  • Change of the The World Health Organization Quality of Life (WHOQOL) over time(Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment))
  • Change of the The General Self-Efficacy Scale over time(Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment))
  • Change of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time(Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment))

研究者

发起方
Koç University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ceren Acarturk

Associate Professor

Koç University

研究点 (1)

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