跳至主要内容
临床试验/CTRI/2021/08/035844
CTRI/2021/08/035844招募中不适用

Effect of music therapy as add on treatment for patients with depression: analytical study with blinding of assessors

MGM medical college and hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年8月23日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
To assess the efficacy of music therapy added to standard pharmacological care in comparison with standard pharmacological care alone, for the treatment of depression by comparing severity of depression using Hamilton rating scale for depression

研究概览

简要总结

Randomised trial, parallel groups, to assess the effect of music therapy as add on treatment with pharmacological care for treatment of patients with depression compared to pharmacological care alone using hamilton rating scale for depression and WHO QOL survey at baseline, post therapy and at 4 month follow up, 7 sessions of 1 hour each t 10+-5 days

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • •Patients attending OPD or IPD of psychiatry department.
  • •Patients of both sex in age group of 18 to 60 years •Patients with diagnosis of moderate to severe unipolar depression (HAM-D Score >17) •Recurrent depressive disorder with current episode of moderate to severe depression.

排除标准

  • 1 Patients suffering from depression with psychotic features.
  • 2 Patients with sensory impairment like hearing 3 Patients with High suicide risk (C-SSRS- positive response in the suicidal thoughts section, item 4 or 5 in last 30 days or positive response in suicidal behavior section item 6 in last 90 days) 4 Patients requiring more than two antidepressants or adjuvant medications except benzodiazepines or melatonin for sleep 5 Patients requiring any additional treatment like ECTs or psychotherapy 6 Patients with any other co morbid psychiatric or medical illness.

结局指标

主要结局

To assess the efficacy of music therapy added to standard pharmacological care in comparison with standard pharmacological care alone, for the treatment of depression by comparing severity of depression using Hamilton rating scale for depression

时间窗: Baseline, post therapy or 2 and 1/2 months and 4 months follow up

次要结局

  • To assess and compare the participants Quality of life using WHO-QOL BREF scale(Baseline, post therapy or 2 and 1/2 months and 4 months follow up)

研究者

申办方类型
Private medical college

研究点 (1)

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Use of Music therapy for treating depression | 临床试验