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临床试验/NCT04128644
NCT04128644已完成不适用

Thoughts and Health - Preventing Depression in Adolescents

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Depressive episode

研究概览

简要总结

This study aims to test the feasibility of implementing an Icelandic cognitive-behavioral program designed to prevent depression, called "Thoughts and Health" in a Swedish school setting. The investigators will also evaluate whether implementation of the program has an impact on the participating students, regarding both their mental health and their success in finishing junior high school with passing grades.

详细描述

Clinical depression is a crucial problem among adolescents. In eighth grade more than half of all students experience headaches, stomach pain, stress, feeling down, and difficulties sleeping. Adolescents affected by depression at a young age are at greater risk of experiencing depressive symptoms as adults, with serious impacts on their quality of life and ability to work. Recent reports from the National Board of Health and Welfare have shown that depression is increasing among adolescents and there is now focus on implementing practice-oriented preventative programs for youth.

Studies by members of our research team have shown that a cognitive-behavioral, developmentally-based intervention program, called "Thoughts and Health", prevented initial episodes of depression and/or dysthymia in adolescents for up to 12 months after program completion.

This study aims to test the feasibility of implementing that program in a Swedish school setting, while also collecting and analyzing preliminary results regarding the potential impact of the program on number of students developing depressive symptoms and the number passing junior high school with full grades.

This is an intervention study with a control group. Students from two Swedish junior high schools will be identified as "at-risk" and invited to participate in the program (n=40), while students from two other schools will act as controls (n=40). All participating students will be followed from study start (baseline) and 1, 6, 12, and 18 months after program completion. Results will include quantitative clinical measures, qualitative focus group discussions, and students' final grades. Two courses of the program will be run over two school years. This study involves close collaboration between academia, primary care, and the community.

This is to our knowledge the first study in Sweden that employs a longitudinal design to evaluate the effects of a school program aimed at preventing depression in adolescents.

研究设计

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

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eight grader (school)
  • •Completed Childrens Depression Inventory (CDI) screening
  • •Able to understand Swedish both orally and written to a level that he/she can complete forms and questionnaires by themselves

排除标准

  • •Current or past depression
  • •Unable to function in a group session
  • •Current psychotherapeutic treatment
  • •Past or current suicidal thoughts or attempts

研究组 & 干预措施

Standard of care+Thoughts & health

Other

12 sessions of Thoughts & Health. Baseline questionnaires and follow up assessments

干预措施: Thoughts & health (Behavioral)

Standard of care+Thoughts & health

Other

12 sessions of Thoughts & Health. Baseline questionnaires and follow up assessments

干预措施: Treatment as Usual (Other)

Standard of care

Other

Baseline questionnaires and follow up assessments, intervention as usual Student Health

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Depressive episode

时间窗: 18 months

Number of participants that have scores that indicate a depressive episode. Questionnaire CDI (Children Depression Inventory), CDI has 27 items scores, each item range from 0-3, above the 90th percentile indicate depressive problems, 90th percentile indicate depressive episode.

次要结局

  • Complete grades(18 months)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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