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临床试验/NCT03540927
NCT03540927已完成不适用

Impact of a Multicomponent Group Intervention on Psychosocial Well-being of Rehabilitated Entrepreneurs in a Conflict-affected Area of Pakistan: A Randomised Controlled Trial

Human Development Research Foundation, Pakistan1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2018年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
235
试验地点
1
主要终点
Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

Conflict and unrest over three decades has resulted in significant economic decline in Khyber Pakhtunkhwa (KP) and Federally Administered Tribal Areas (FATA) of Pakistan and these now rank among the poorest regions in the country. The 2009-10 insurgency and subsequent security operations affected both regions and displaced an estimated 2 million people. The severe damage to infrastructure and livelihoods negatively impacted the social and economic fabric of the entire region. As peace has returned to the area, the Economic Revitalization of KP and FATA (ERKF) project, established in 2012 and supported by the World Bank, is working for the rehabilitation of small and medium enterprises (SMEs), with the aim of creation and restoration of jobs. This support is in the form of grants given to individuals who use the funds to establish and run a business in their locality.

Epidemiological studies from the area have shown high rates of common mental disorder (eg., depression, anxiety) in the general population (Husain et al, 2006, Khan et al 2016). Such conditions have a serious impact on the well-being, functioning and productivity of affected individuals (World Health Organization, 2000). For example, in the USA, Depressive Disorders have been estimated to cost the economy over US$210 billion per annum, largely due to reduced productivity (Greenberg et al, 2015). The economic rehabilitation of a population exposed to a humanitarian crisis, and therefore at greater risk of depression, must include interventions to reduce mental morbidity so the individuals are able to function better and potentially improve their long-term productivity.

The Human Development Research Foundation, in collaboration with the World Bank, has adapted a 5-session group intervention from WHO Problem Management Plus program, tailored to the needs of small and medium enterprise owners affected by the prolonged conflict in KP and FATA areas of Pakistan. This intervention (Problem Management Plus adapted for entrepreneurs) is based on established cognitive behavioral strategies previously tested in Pakistan (Rahman et al, 2016). The goal of the intervention is to improve psychological capital,reduce psychosocial distress leading to, increased productivity in the long-term. The intervention will be evaluated using a two arm, single blind randomized controlled trial.

研究设计

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

盲法说明

Only outcome assessors will be blind to allocation status of the participants.

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

  • All small and medium entrepreneurs, leading SMEs and family businesses in situations of fragility encountered in KP/FATA, Pakistan, who received a cash transfer for rehabilitation of their businesses by Economic Revitalization of Khyber Pakhtunkhwa and FATA (ERKF), Pakistan.

排除标准

  • 未提供

结局指标

主要结局

Patient Health Questionnaire (PHQ-9)

时间窗: Primary end point is percentage change in the prevalence of psychological distress in the intervention arm as compared to the control arm at 3 months post intervention.

The primary outcome is change in the prevalence of psychological distress as measured by PHQ-9 in the intervention arm as compared to the control arm. The 9-item Patient Health Questionnaire (PHQ-9), incorporates DSM-IV depression diagnostic criteria with other key major depressive symptoms (Kroenke et al, 2001). Participants rate their responses on a 4-point Likert scale ranging from not at all to nearly every day. The PHQ-9 total severity score ranges from 0 to 27. The PHQ-9 has been validated in the Urdu language, showing adequate sensitivity and specificity (Husain et al 2006) and has been used in recent studies in KP (Rahman et al, 2016).

次要结局

  • Multi-dimensional Scale for Perceived Social Support (MSPSS)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
  • GAD-7(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
  • Business behaviors(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
  • Psychological Capital Questionnaire(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
  • Long term productivity(12 months follow-up)
  • WHO-5 Well being index (WHO-5)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
  • Individual Entrepreneurial Orientation (IEO)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)

研究者

发起方
Human Development Research Foundation, Pakistan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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