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临床试验/NCT06633679
NCT06633679进行中(未招募)不适用

Se Cuida - Internet-delivered Cognitive Behavioral Therapy for Anxiety and Depressive Symptoms in Brazilian Emerging Adults

Linkoeping University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
2
主要终点
Depression, Anxiety and Stress Scale - DASS-21

研究概览

简要总结

This study aims to investigate the effects of a selfguided internet-based cognitive behavioral therapy (ICBT) program on depressive and anxiety symptoms in young Brazilian adults. Treatment group will be compared to a waiting list control group. Participants will be recruited in Brazil with a nationwide recruitment.

详细描述

This is a randomized controlled trial carried out to evaluate the effects of an internet-based cognitive behavioral program for depressive and anxiety symptoms in young Brazilians adults. The program consists of 8 weeks of treatment and is carried out through an online platform. During treatment, participants have the support of a therapist who can be reached on demand via the platform's text messaging channel. The program was adapted to Brazilian culture from previous work.

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 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (1) age between 18 and 24 years old; (2) have a device with Internet access that allows access to the platform; (3) speak and read Brazilian Portuguese.

排除标准

  • (1) having a severe psychiatric diagnosis such as bipolar disorder and schizophrenia; (2) having severe suicidal ideation or reported suicidal intent; (3) reporting substance abuse; (4) being in an ongoing psychological and/or psychiatric treatment; (5) changing psychiatric medication less than 3 months before the treatment starts; (6) scoring extremely severe on all three subscales of DASS-21 (28+ for depression, 20+ for anxiety and 34+ for stress.

结局指标

主要结局

Depression, Anxiety and Stress Scale - DASS-21

时间窗: In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks

Measures depression, anxiety, and stress symptoms in the last week. Primary outcomes will be depressive and anxiety subscales. The instrument consists of 21 questions evaluated with a Likert Scale ranging from 0 (does not apply to me at all) to 3 (applied to me very much or most of the time). The scores for each subscale were proposed by the original authors and range from normal, mild, moderate, severe, and extremely severe symptomatology. The severity rating can be easily accessed in the Brazilian version.

次要结局

  • Insomnia Severity Index (ISI)(In recruitment and at the end of treatment after 8 weeks)
  • Almost Perfect Scale - Revised (APS-R)(In recruitment and at the end of treatment after 8 weeks)
  • Brunnsviken Brief Quality of Life Scale (BBQ)(In recruitment and at the end of treatment after 8 weeks)
  • Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV)(In recruitment and at the end of treatment after 8 weeks)
  • Social Media Disorder Scale-Short Form (SMDS-SF)(In recruitment and at the end of treatment after 8 weeks)
  • Depression, Anxiety and Stress Scale - DASS-21(In recruitment and at the end of treatment after 8 weeks)

研究者

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

Gerhard Andersson

PhD

Linkoeping University

研究点 (2)

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