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临床试验/NCT06532097
NCT06532097已完成不适用

Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients: a Pilot-study

Max-Planck-Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2023年3月1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
53
试验地点
1
主要终点
PHQ-9

研究概览

简要总结

It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written consent for voluntary study participation
  • Between 18 and 65 years of age
  • Current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to ICD-10 (F32.0, F32.1)
  • Internet access and email address to answer electronic questionnaires
  • Ability to read German

排除标准

  • Acute suicidality
  • Pregnancy and breastfeeding
  • Currently undergoing psychological treatment
  • Current use of psychotropic medication
  • Neurological or internal medical disease
  • Diagnosis of a severe major depression or dysthymia according to ICD-10 (F32.2, F32.3, F33.2, F33.3, F34.1)
  • Diagnosis of a psychotic disorder according to ICD-10 (F20-F29) in the life history
  • Diagnosis of a bipolar disorder according to ICD-10 (F31) in life history
  • Acute substance abuse (e.g., drug use or excessive alcohol and nicotine use)
  • Diagnosis of dissociative disorder (F44) in life history

结局指标

主要结局

PHQ-9

时间窗: pre to post: 12 weeks

Patient Health Questionnaire

次要结局

未报告次要终点

研究者

发起方
Max-Planck-Institute of Psychiatry
申办方类型
Other
责任方
Sponsor

研究点 (1)

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