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临床试验/NCT00233142
NCT00233142已完成2 期

Expressive Writing: Complementary Treatment for Diabetes

Syracuse University8 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
187
试验地点
8
主要终点
hemoglobin A1C (indicator of blood glucose)

研究概览

简要总结

This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

详细描述

Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms.

Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes mellitus made after age 24

排除标准

  • Diabetes-related emergency room visit within 3 months prior to study entry
  • Use of psychiatric medication within 3 months prior to study entry
  • Visual or manual limitations that preclude reading and writing
  • Use of insulin within the first year of diabetes diagnosis
  • Pregnancy or plan to become pregnant

结局指标

主要结局

hemoglobin A1C (indicator of blood glucose)

时间窗: baseline, 4 months, 8 months, 12 months, and 16 months

次要结局

  • Diabetes symptoms(baseline, 4 months, 8 months, 12 months, and 16 months)
  • quality of life(baseline, 4 months, 8 months, 12 months, and 16 months)
  • depression(baseline, 4 months, 8 months, 12 months, and 16 months)
  • cognitive function(baseline, 4 months, 8 months, 12 months, and 16 months)
  • stress levels(baseline, 4 months, 8 months, 12 months, and 16 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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