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临床试验/NCT07500142
NCT07500142撤回不适用

Evaluation of the Group Problem Management Plus (Group PM+) Pilot Study in Oromia and Amhara Regional States, Ethiopia

International Food Policy Research Institute1 个研究点 分布在 1 个国家开始时间: 2022年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Mental health index

研究概览

简要总结

Mental health disorders are among the leading causes of the global health-related burden. Mental health disorders are exacerbated by poverty and exposure to adversity like conflict and adverse shocks. Despite the high prevalence, adequate care for mental illness is mainly inaccessible in low- and middle-income countries. Given the bidirectional link between poverty and mental health and the limited mental health treatment in many low income settings, combining antipoverty interventions with psychotherapy delivered by non-specialists may be promising. Using a randomized control trial design, this study will compare the impact of a psychotherapy program, group Problem Management plus, with and without a one-time lump sum cash transfer on mental health, daily activities, and economic outcomes among Productive Safety Net Program clients in the regions of Amhara and Oromia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • have signs and symptoms of depression or dysfunction as measured by the PHQ-9 and WHODAS 2;
  • be between 18 and 59 years old,
  • be the main decision-maker or spouse of the main decisionmaker.

排除标准

  • individuals with signs of severe depression or suicide

结局指标

主要结局

Mental health index

时间窗: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

Mental health index will be composed of 5 mental health indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 5 indicators are: * PHQ-9 - total score from 9 questions, standardized unit using control mean and SD * Perceived stress scale - total score from 10 questions, standardized using control mean and SD * Post-traumatic stress, PCL-C - total score from 6 questions, standardized using control mean and SD * General Anxiety Disorder 7 - total score from 7 questions, standardized using control mean and SD * WHO Disability Assessment Schedule 2.0 - total score from 12 questions, standardized using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index.

Economic index

时间窗: 12 months after the gPM+ sessions end

Economic index will be composed of 4 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 4 indicators are: * The total value of productive assets- total value transformed using inverse-hyperbolic sine (IHS), then standardized using control mean and SD * Total value of monthly per capita expenditures - total value of food and non-food consumption transformed using HIS, then standardized using control mean and SD * Food insecurity experience scale- total score recoded so higher values indicates more food secure, then standardized unit using control mean and SD * Savings- binary indicator that equals one if money was deposited in savings account, standardized unit using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index

Time use

时间窗: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

Time use index will be composed of 3 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 3 indicators that will be used to construct the aggregate time use index are: * Non-economic activities: total hours spent in non-economic activities in the last 24 hours, converted to standardized unit using control mean and SD * Income generating activities: total hours spent in income generating activities in the last week, converted to standardized unit using control mean and SD * Other activities: summation of number of other activities participated, converted to standardized unit using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index.

Childcare

时间窗: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

Childcare index will be composed of 3 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 3 indicators that will be used to construct the aggregate childcare index are: * Childcare - total number of activities, converted to standardized unit using control mean and SD * Child discipline: total score transformed so that higher values equal more favorable outcomes. Total score is then converted to standardized unit using control mean and SD. * Child neglect : total score transformed so that higher values equal more favorable outcomes. Then total score is converted to standardized unit using control mean and SD. As a robustness, we will also assess individual indicators that make up the summary index.

次要结局

  • Time and risk preference(Immediately after gPM+ session ends and 12 months later)
  • Value of Investments in last 12 months(12 months after gPM+ ended)
  • Intimate Partner Violence (IPV)(12 months after gPM+ ends)
  • Alcohol use (3 item)(Immediately after gPM+ session ends and 12 months later)
  • Khat consumption(Immediately after gPM+ session ends and 12 months later)
  • Tension reduction checklist(Immediately after gPM+ session ends and 12 months later)
  • Brief Cope (shortened to 6 items)(Immediately after gPM+ session ends and 12 months later)
  • Multi-dimensional Scale of Perceived Social Support(Immediately after gPM+ session ends and 12 months later)
  • New general self-efficacy(Immediately after gPM+ session ends and 12 months later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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