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临床试验/NCT01989247
NCT01989247已完成不适用

Self-management of Depression and Anxiety. A Randomized Controlled Trial.

University of Aarhus74 个研究点 分布在 1 个国家目标入组 853 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
853
试验地点
74
主要终点
Depressive Symptoms (Beck's Depression Inventory (BDI-II))

研究概览

简要总结

The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety and depression will benefit from a self-management training program with respect to: 1) Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of Health Related Quality of Life (HRQoL)

详细描述

  • The intervention is a Danish adaption of The Chronic Disease Self-Management Program developed by The Stanford Patient Education Research Center, The Expert Patient Program Community Interest Company (EPPCIC), and The English National Health Service (NHS).
  • The Danish adaptation has been performed by The Danish Committee for Health Education.

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

  • >= 18 years of age
  • Suffering from anxiety and/or depressive symptoms
  • Voluntary participation

排除标准

  • Potential suicidal behavior
  • Potential aggressive behavior
  • Significant cognitive impairment

结局指标

主要结局

Depressive Symptoms (Beck's Depression Inventory (BDI-II))

时间窗: Change from 1) Pre-randomization, to 2) Three months post-intervention

State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))

时间窗: Change from 1) Pre-randomization, to 2) Three months post-intervention

Only the State-anxiety subscale of the STAI is used

Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))

时间窗: Change from 1) Pre-randomization, to 2) Three months post-intervention

Only the following subscale is used: "Obtain help from Community, Family, Friends Scale"

Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))

时间窗: Change from 1) Pre-randomization, to 2) Three months post-intervention

Only the following subscale from the IPQ-R is used: "Personal Control"

次要结局

  • Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)(Change from 1) Pre-randomization, to 2) Three months post-intervention)
  • Exercise Behaviors (Stanford Patient Education Research Center)(Change from 1) Pre-randomization, to 2) Three months post-intervention)
  • Self-efficacy ("Control/Manage Depression Scale from: "Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))(Change from 1) Pre-randomization, to 2) Three months post-intervention)
  • Health related symptoms(Change from 1) Pre-randomization, to 2) Three months post-intervention)
  • Sleep Quality (The Pittsburgh Sleep Quality Index)(Change from 1) Pre-randomization, to 2) Three months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Søren Christensen

Senior Researcher

University of Aarhus

研究点 (74)

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