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临床试验/NCT04721678
NCT04721678已完成不适用

INDIGO - Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

Linkoeping University2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年1月22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
113
试验地点
2
主要终点
Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)

研究概览

简要总结

The aim of the study is to test the efficacy of a treatment for depression based on interpersonal psychotherapy (IPT). The treatment will be accessed via an internet platform built for this study. A therapist will provide support weekly, as well as on-demand when needed. The treatment lasts for 10 weeks.

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

  • A diagnosis of Major depressive disorder (as indicated by the MINI 7.0 Neuropsychiatric interview) and/or depressive symptoms equal to or more severe than mild depression on the MADRS-S (equal to or above 13 points) and/or BDI (equal to or above 14 points).
  • Age of at least 18 years old.
  • Adequate ability to speak, write, and read Swedish.
  • Internet access for the duration of the study.

排除标准

  • Ongoing substance abuse.
  • Suicidal plans.
  • A diagnosed personality syndrome (as diagnosed before the study by a licensed psychiatric healthcare professional).
  • Other ongoing psychological treatment.
  • Other severe psychiatric comorbidity that requires specialized care (e.g. anorexia nervosa, psychosis).
  • Recent changes in psychotropic medication or planned changes during the initial treatment period.

结局指标

主要结局

Change on Montgomery Åsberg Depression Rating Scale (MADRS-S)

时间窗: Before the treatment, during week 1 to 10 of the treatment, after 11 weeks. Follow-up one year after the start of the treatment.

Depression inventory, consists of 9 items measuring symptoms of major depressive disorder. Each item are scored between 0 and 6 points, resulting in a total sum between 0 and 54. Cut-offs are: 0-12 No substantial depressive symptoms, 13-19 mild depressive symptoms, 20-34 moderate depressive symptoms, 35-54 severe depressive symptoms.

次要结局

  • Change on Brunnsviken Brief Quality of Life Inventory (BBQ)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)
  • Change on Generalized Anxiety Disorder 7-Item Scale (GAD-7)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)
  • Change on Reflective Functioning Questionnaire-8 item version (RFQ-8)(Before treatment, after 11 weeks, following one year after the start of the treatment.)
  • Change on Beck Depression Inventory-II (BDI-II)(Before treatment and after 11 weeks, follow-up one year after the start of the treatment.)

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

Professor

Linkoeping University

研究点 (2)

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