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临床试验/NCT04858789
NCT04858789已完成不适用

Effectiveness of a Culturally Adapted Cognitive Behavioral Intervention to Reducing Psychological Distress and Improving Well-Being Among University Students During the COVID-19 Pandemic

Koç University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年6月24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
17
试验地点
1
主要终点
Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time

研究概览

简要总结

The effectiveness study for Culturally Adapted Cognitive Behavioral Intervention will be conducted with university students to measure if this intervention if effective for decreasing the university students' psychological distress and increase their well-being during the COVID-19 pandemic. Potential participants will be given an informed consent and included in a screening procedure to decide their eligibility. 100 participants (50 in experimental and 50 in control group-randomly assigned) who pass the screening procedure will be invited to the effectiveness study. The experimental group will receive an 8-session intervention while the control group will receive information about the freely available psychological support options. The measurements will be conducted three times; one week before, one week after and five weeks after the intervention.

详细描述

Rapid increase in the COVID-19 cases and COVID-19 related deaths were followed by several precautions including the daily usage of masks, social distancing, temporary closure of work places, government departments, schools and universities. Due to these adversities and necessary precautions, people experience psychological distress and symptoms of depression and anxiety during the pandemic. Research shows that university students are at risk for developing psychological distress and common mental health disorder symptoms, and providing psychological interventions for university students may decrease the mental health problems of the students. However, considering the social distancing, these interventions must be delivered online. There are some studies indicate that online interventions may be effective as face-to-face interventions. Considering the mental health support need that the university students have during COVID-19, addressing this need may be beneficial for the mental health of university students in these uncertain times. There are various studies that showed the effectiveness of various form of interventions and one of them is Culturally Adapted Cognitive Behavioral (CA-CB) intervention developed by Hinton. CA-CB interventions were tested with adolescents and women in Turkey and found to decrease the psychological symptoms of these people. CA-CB interventions are based on the cognitive behavioral approach's principles but also include emotion regulation techniques, mindfulness and stretching exercises.

The investigators propose to conduct a randomized controlled trial in which they aim to apply a preventive culturally adapted cognitive behavioral intervention (CA-CBI) which is adapted to university students and COVID-19 related stressors. After the adaptation process is completed, the investigators will distribute an online survey to university students for the recruitment. The university students who would like to participate in the intervention study and are eligible to participate will be included. The investigators will randomly assign them into two arms (control and CA-CBI) and then deliver CA-CBI in a group format to the intervention arm. The investigators will examine whether the psychological distress levels and common mental health problems of the students in the intervention arm is decreased compared to the control arm. The investigators will examine the study outcomes of the both arms at three times: Pre-assessment (1 week before the intervention), post-assessment (1 week after the intervention) and follow-up assessment (1 month after the post-assessment). A process evaluation according to the WHO will be completed with 5 study completers, 5 drop-outs and 2 facilitators to evaluate the feasibility of delivering CA-CBI.

Although the CA-CBI was delivered in Turkey to different populations before, it was not tested with university students yet. In addition, there are scarce publications on the online delivered group interventions and to our knowledge, there is neither such research conducted during the pandemic nor research about the efficacy of online synchronous interventions in Turkey. The investigators will contribute to the literature by adapting CA-CBI to the university students who are affected from COVID-19. In addition, they will also add to the literature on online interventions by delivering CA-CBI online in a group format.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years or above
  • Being a university student
  • Scoring 16 or above on Kessler Psychological Distress Scale (K10)
  • Scoring 14 or belove on Patient Health Questionnaire-9 (PHQ-9)

排除标准

  • Being older than 30 years
  • Imminent suicidal risk
  • Living outside of Turkey
  • Having any type of psychiatric disorder
  • Receiving any specialized psychological or psychiatric treatment at the time of application to the study

结局指标

主要结局

Comparison of changes of the Kessler-10 Psychological Distress Scale (K10) over time

时间窗: Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)]

Kessler-10 Psychological Distress Scale is a 10-item scale that aims to measure the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) providing a range between 10 and 50. Higher scores indicate more severe psychological distress.

次要结局

  • Comparison of changes of the World Health Organization (Five) Well-Being Index (WHO-5) over time(Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment))
  • Comparison of changes of the General Anxiety Disorder-7 (GAD-7) over time(Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment))
  • Comparison of changes of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time(Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment))
  • Comparison of changes of the Patient Health Questionnaire-9 (PHQ-9) over time(Change from baseline (One week before the intervention) to follow-up assessment (13 weeks after the pre-assessment)])

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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