ISRCTN58007098已完成不适用
Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: a randomised controlled trial
Ruhr University of Bochum (Germany)0 个研究点目标入组 315 人开始时间: 2009年5月11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
- 315
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diabetes mellitus type 2 diagnosed at least 6 months before entering the trial
- •2. Both males and females, 65 to 85 years of age
- •3. Minor depression (adapted from the Diagnostic and statistical manual of mental disorders [4th edition, text revision] [DSM-IV-TR] research criteria: we require 3-4 symptoms rather than 2-4 symptoms and a past history of major depression is not an exclusion criteria), or mild major depression (according to DSM-IV-TR criteria 5 to 6 depressive symptoms)
- •4. Living near the coordination institution where treatment will take place
- •5. Signed written informed consent
排除标准
- •1. Serious violent, homicidal, or suicidal ideation; particularly clinically significant suicide risk or history of attempted suicide within the past 2 years
- •2. History of schizophrenia, psychotic symptoms or bipolar disorder
- •3. Organic brain syndrome, dementia or substantial cognitive impairment
- •4. Alcohol or substance abuse or dependence in the past 12 months (other than nicotine abuse/dependence)
- •5. Insufficient ability to understand German
- •6. Regular participation in a self-help-group (minimum 4 sessions in the last 12 months)
- •7. Psychotherapy (in the past 3 months)
- •8. Bereavement and grief reaction (loss <3 months)
- •9. Planned hospital admission next 3 months
- •10. Medical contraindication for physical activity
- •11. History of severe acute or chronic medical disorder (other than diabetes) ? which would probably impair trial commitment or lead to biased trial results (based on the critical ap-praisal of the investigator)
- •12. Patients who have taken antidepressants or mood stabilizing medication regularly over the 30 days prior to screening, patients who have taken fluoxetine regularly over the 60 days prior to screening, or patients on depot neuroleptic medication over the 5 inter-injection intervals prior to screening
- •13. History of severe acute or chronic medical disorder (other than diabetes) ? in the opinion of the investigator - preventing trial commitment or confounding interpretation of trial results
- •14. Blood chemistries alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) value(s) greater than or equal to three times the upper limit of normal prior to randomisation; estimated glomerular filtration rate (GFR) lower than 30; blood chemis-tries thyroid-stimulating hormone (TSH) values lower than 0.5 mU/l or greater than 5 mUl adapted to reference ranges of the laboratory
- •15. Legal incompetence or legal guardianship
- •16. Participation in competing trials
研究者
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