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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1日最近更新:
适应症
干预措施

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
否

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

研究组 & 干预措施

Usual care

Other

Participants in this group received usual care only.

干预措施: Usual care (Other)

Minimal Psychological Intervention

Experimental

Participants allocated to this group not only received the usual care as given by their family physicians, but also accepted biweekly minimal psychological intervention via telephone during six weeks.

干预措施: Minimal psychological intervention (Behavioral)

Minimal Psychological Intervention

Experimental

Participants allocated to this group not only received the usual care as given by their family physicians, but also accepted biweekly minimal psychological intervention via telephone during six weeks.

干预措施: Usual care (Other)

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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