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临床试验/CTRI/2019/05/018956
CTRI/2019/05/018956进行中(未招募)不适用

Effect of psychoeducation on short-term outcome in patients with late life depression: A Randomised Control Trial

KING GEORGES MEDICAL UNIVERSITY1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2019年9月5日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
154
试验地点
1
主要终点
Psychoeducation will improve outcome in case group patients with late life depression.

研究概览

简要总结

This study is a randomised, parallel group, placebo controlled trial to see the effect of psychoeducation along with treatment as usual on short-term outcome in 154 patients with depression aged 60 years and above. It is a single centred study to be conducted in the Department of Geriatric Mental Health, King George’s Medical University, Lucknow, Uttar Pradesh, India. The intervention is that psychoeducation video will be shown to the case group and the control group will be shown placebo-psychoeducation  video. The primary outcome is that psychoeducation will improve depression in the case group patients at 4 weeks. Since there will be improvement in depression, hence the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) will also lower down.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1Patients aged 60 years and above 2Patients giving the informed consent 3Patients scoring 24 and above in the Hindi Mental Status Examination (HMSE) 4Patients with first episode of depression and no previously diagnosed psychiatric disorder 5Patients who have been clinically diagnosed with depression 6Patients’ diagnosis will be confirmed on Mini International Neuropsychiatric Interview 6.0 (MINI 6.0).

排除标准

  • 1 Patients having any severe medical illness 2 Patients with hearing impairment or language problem or any other issue which is can be serious impediment to the study.

结局指标

主要结局

Psychoeducation will improve outcome in case group patients with late life depression.

时间窗: 4 weeks

次要结局

  • Giving psychoeducation will lower down the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) in case group patients.(4 weeks)

研究者

发起方
KING GEORGES MEDICAL UNIVERSITY
申办方类型
Government medical college

研究点 (1)

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