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临床试验/NCT03544450
NCT03544450已完成不适用

Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal

Centre for Victims of Torture, Nepal0 个研究点目标入组 287 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
287
主要终点
The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory

研究概览

简要总结

Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.

The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting.

Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings.

If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.

详细描述

Statement of problem

Psychosocial interventions, such as counselling, are effective in improving social functioning in common mental disorders. Specifically, culturally adapted psychological treatments are effective in the treatment of depression, according to a recent meta-analysis.

Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task-shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment.

In the MANAS trial in India, for example, those receiving the intervention were 55% more likely to recover from common mental disorders than the control group in public health facilities. The stepped-care intervention was provided by NMHWs who had received a two-month training in counselling. In Pakistan, a psychological treatment delivered by Lady Health Workers (NMHWs) resulted in 78% reduction in maternal depression, compared with usual care.

In Nepal, the need for psychosocial interventions led by NMHWs is high because of the very limited number of mental health professionals. Centre for Victims of Torture (CVICT) has extensive experience in developing psychosocial counseling services and training counsellors. CVICT has experienced that even a short intervention, including only 1-5 counselling sessions, leads to decreased mental distress. Positive feedback has been given both by the patients and the people working in primary health care. However, no rigorous research has been conducted on the effectiveness of counselling on the symptoms of common mental disorders. This will be the first study comparing the effectiveness of psychosocial counseling and enhanced usual care to enhanced usual in rural Nepal.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • GHQ-12 ≥ 6
  • Willing to participate in the intervention and research program
  • Able to communicate fluently in Nepali and to participate the required visits
  • Resident in Dang for the subsequent 10 months

排除标准

  • Age < 16
  • GHQ-12 < 6
  • Signs of severe mental health problems (i.e., psychotic features)
  • Severe illnesses or conditions requiring immediate attentions( i.e., suicidal)
  • Not willing to participate in the intervention and research program

研究组 & 干预措施

Psychosocial counselling + Enhanced usual care (EUC)

Experimental

This arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker

干预措施: Psychosocial counselling (Behavioral)

Psychosocial counselling + Enhanced usual care (EUC)

Experimental

This arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker

干预措施: Enhanced Usual Care (Other)

Enhanced Usual Care (EUC)

Active Comparator

This arm receives enhanced usual care from health worker

干预措施: Enhanced Usual Care (Other)

结局指标

主要结局

The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory

时间窗: 0 months, 1 month, 6 months

The range of scale is 0-63 scores and higher scores indicate higher levels of depression. Reduction of 50% or more from initial BDI score indicates response. The instrument is used at baseline, 1 month and 6 months in both groups.

次要结局

  • Change in the symptoms of depression assessed by Beck Depression Inventory(0 months, 1 month, 6 months)
  • Change in the symptoms of anxiety assessed by Beck Anxiety Inventory(0 months, 1 month, 6 months)
  • Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II(0 months, 1 month, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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