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临床试验/NCT07386574
NCT07386574招募中不适用

Testing a Contextualized and Digitalized WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module in Primary Care Settings of Pakistan: A Feasibility Cluster Randomized Controlled Trial

Pakistan Institute of Living and Learning1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Feasibility measures

研究概览

简要总结

The aim of study is to:

  1. To contextualize, adapt, customize and digitalize WHO's Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG); Substance Use Disorders Module (SUD module) V 2.0 for primary care settings (PCPs) in Pakistan.
  2. To test the feasibility and acceotability of the e-mhGAP-IG (SUD module) training program in a feasibility cluster randomized controlled (cRCT) trial to enable mental health services in primary health care settings in Pakistan.

The proposed study includes contextualization, adaptation, customization, and a feasibility cRCT of e-mhGAP-IG (SUD module) V 2.0 by constituting a combination of traditional and technological approaches of eHealth (mHealth, blended learning, and telemedicine) enabling mental health services in primary care settings to be well informed and accessible. This intervention will empower 300 Primary Care Physicians (PCPs) based in Primary Care Units (PCUs) from urban settlements and Basic Health Units (BHUs) from rural settlements in three major cities, Karachi, Lahore, and Rawalpindi, Pakistan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Primary and non-specialized healthcare providers working in the identified health facilities for this study across three targeted cities; willing to give informed consent for participation in this trial.

排除标准

  • Any primary and non-specialized healthcare provider who is not permanently working in the selected health facilities, has no access to a smart mobile phone and/or internet connection; and is uncomfortable using a mobile phone.

研究组 & 干预措施

e-mhGAP-IG-SUD Intervention Group

Experimental

Participants randomized to this arm will receive a total of eight bi-weekly training sessions on the use of the adapted e-mhGAP-IG-SUD-Urdu mobile application. Training will focus on improving screening, diagnosis, and management of young people with SUD and referral to specialized services where needed.

干预措施: mhGap IG SUD Module Intervention Training (Other)

Control Group

Active Comparator

Participants randomized to this arm will continue with routine practices and standard care for SUD management as currently being delivered.

干预措施: Control (Other)

结局指标

主要结局

Feasibility measures

时间窗: From enrollement to the end of intervention at 4 weeks

Feasibility will be determined by recruitment and retention rates of participants throughout the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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