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临床试验/NCT04911829
NCT04911829招募中不适用

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Modum Bad2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Modum Bad
入组人数
80
试验地点
2
主要终点
Change in Depressive symptoms

研究概览

简要总结

The study evaluates cost and effect of inpatient versus outpatient treatment of dysthymia, as well as investigates the processes through which psychotherapy works in treating dysthymia.

详细描述

Inpatient treatment allows a more intensive treatment and allows the patient to be in a context where it is possible to focus on the processes in therapy with minimal interruption. Outpatient treatment is much less intensive but allows the treatment process to unfold in the context where the patient is experiencing the problems that brought them to therapy. It is not clear which of the contexts will be more effective in alleviating symptoms of dysthymia. Further, as dysthymia is a very costly disease for society it is of interest to know if the two treatments are cost-effective, and which one is the most cost effective.

A great paucity on dysthymia research ha left the psychotherapy field without an understanding of the processes through which dysthymia is changed. This study will investigate the change process through frequent assessments of common factors, psychological processes, symptoms, heart rate variability and cognitive attention bias.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site: Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5); which includes an International classification of disorders-10 (ICD-10) diagnosis of depression, dysthymia, recurrent depression. unsuccessful previous treatments. living within driving distance from the treatment facilities.

排除标准

  • current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.

结局指标

主要结局

Change in Depressive symptoms

时间窗: Once every week for the 12 weeks of active psychotherapy

Patient health questionnaire

Change in Cost of living with dysthymia

时间窗: pre therapy, one-year and 10 years

cost of living with dysthymia, cost-effectiveness of therapy at one-year and at 10 years. Information will be gathered from various registries and combined to a sum of money.

次要结局

  • Common factors-expectations(Once every week for the 12 weeks of active psychotherapy)
  • Common factors-credibility(Once every week for the 12 weeks of active psychotherapy)
  • Emotional psychological processes(Once every week for the 12 weeks of active psychotherapy)
  • cognitive psychological processes(Once every week for the 12 weeks of active psychotherapy)
  • metacognitive psychological processes(Once every week for the 12 weeks of active psychotherapy)
  • Common factors-alliance(Once every week for the 12 weeks of active psychotherapy)
  • Common factors-explanation(Once every week for the 12 weeks of active psychotherapy)
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)(Once every week for the 12 weeks of active psychotherapy)
  • resilience(Once every week for the 12 weeks of active psychotherapy)
  • anxiety Symptoms(Once every week for the 12 weeks of active psychotherapy)
  • loneliness(Once every week for the 12 weeks of active psychotherapy)

研究者

发起方
Modum Bad
申办方类型
Other
责任方
Sponsor

研究点 (2)

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