CTRI/2024/07/071467招募中3 期
Modified Cognitive Behavioural Therapy -I (MCBT-I) with melatonin for acute insomnia in patients undergoing chemotherapy: A Double Blind Randomised Controlled Trial (COMET)
Jawaharlal Institute of Postgraduate Medical Education Research1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Insomnia status assessed by the ISI score
研究概览
简要总结
This is a study to be done in patients undergoing chemotherapy for cancer and suffering from sleeplessness (Insomnia). Eligible patients will receive cognitive behavior therapy. In addition, they will be randomised to 2 groups. One group will receive melatonin for 6 weeks while the other group will receive placebo for 6 weeks. The end point will be improvement in insomnia severity after 6 weeks. This trial will try to see whether addition of melatonin to behaviour therapy will reduce insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of cancer On curative chemotherapy beyond cycle 1 Insomnia as per scale of at least 15 Presence of insomnia after cycle 1 within 4 weeks prior to enrolment Normal organ function able to understand tamil or english.
排除标准
- •Already on anti insomnia medication known psychiatric illnesses Known sleep disorders on medications patients with hematological cancers Primary brain tumors or brain metastasis.
结局指标
主要结局
Insomnia status assessed by the ISI score
时间窗: Insomnia status assessed by the ISI score
次要结局
- Quality of life(6 weeks)
- Symptom severity score(6 weeks)
研究者
Dr Prasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
研究点 (1)
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