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临床试验/NCT02473081
NCT02473081已完成不适用

The Long-term Effect of a Minimal Psychological Intervention on Type 2 Diabetes Patients' Depressive Symptom, Diabetes-related Distress and Glycemic Control

National Cheng-Kung University Hospital0 个研究点目标入组 182 人开始时间: 2012年10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
182
主要终点
Hemoglobin A1c

研究概览

简要总结

The purpose of this study is to determine whether the telephone-delivered Minimal Psychological Intervention (MPI) could improve diabetes' depressive symptom and diabetes-related immediately , as well as HbA1c level in the long-term.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Clinical diagnosis of Diabetes disease

排除标准

  • Were using anti-depression medication
  • With ongoing psychological/psychiatric treatment
  • Had been diagnosed with psychosis (ex. schizophrenia or bipolar disorder)
  • Had severe cognitive problem or hearing impairment
  • Lost their partner within three months

结局指标

主要结局

Hemoglobin A1c

时间窗: Participants were measured during entire follow-up period, an average period of 3 months.

Depressive symptom assessed by CES-D 10

时间窗: At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3)

Depressive symptom score was assessed with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10).

Diabetes-related distress assessed by PAID scale

时间窗: At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3)

Diabetes-specific emotional distress was assessed with the Problem Areas in Diabetes (PAID) scale.

次要结局

未报告次要终点

研究者

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

Ching-Ju Chiu

Assistant Professor

National Cheng-Kung University Hospital

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