Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Depression using the Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The objective of this study is to examine the impact of the "Doing What Matters in Times of Stress" guided self-help handbook, along with phone-based lay helpers sessions, on the psychological well-being, business performance, and incidence of intimate partner violence among women entrepreneurs in Ethiopia.
详细描述
This study aims to evaluate the impact of the "Doing What Matters in Times of Stress Guided" self-help manual on mental distress, business performance, and intimate partner violence experienced by women entrepreneurs in Ethiopia. The study will be conducted in four cities - Addis Ababa, Hawassa, Bahir Dar, and Adama - using a randomized controlled trial (RCT) design. The investigators will screen 5000 potential participants via phone and enroll 1200 eligible women, who will be equally distributed across the four cities. After an in-person baseline survey, the women will be stratified by marital status and city and randomized into the intervention or waitlist control group using a computer-generated random assignment. The intervention group will receive seven phone-based sessions over ten weeks to review the self-help manual materials with a lay helper. Two follow-up surveys will be conducted after the intervention, the first one a month after the completion of the intervention, and the second one twelve months after completion.
This study is a continuation of a pilot study conducted between July 2021 and August 2022 (PRS registration ID - NCT05208723). The current study seeks to build on the pilot study in the following dimensions:
- Increase the sample size to 1200 women entrepreneurs to improve the power of the study to detect the impact of the intervention on business performance outcomes,
- Widen the geographical and contextual coverage,
- Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them,
- Capture the impact on intimate partner violence,
- Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.
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
Randomized using computer-generated randomization at one point in time.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Those who plan to live in the study city in the next six months;
- •Those who can read and speak Amharic and can understand the study questionnaire;
- •Those who have the capacity to provide informed consent;
- •Score 8 or above on the Ethiopian adaptation of Kessler-6
排除标准
- •Kessler 6 score >20;
- •Those who have recent or current suicidal thoughts or plans;
- •Those who have limitations in understanding the study questionnaire;
- •Those who do not have the capacity to provide informed consent;
- •Do not have access to a phone;
- •Not interested in receiving the intervention
结局指标
主要结局
Depression using the Patient Health Questionnaire (PHQ-9)
时间窗: Time Frame: 12 months post intervention
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Stress using the Perceived Stress Scale
时间窗: Time Frame: 12 months post intervention
Minimum score of 0 and a maximum of 40. Higher scores indicate high levels of perceived stress (worse outcome). Investigators will reverse code items 4,5, 7 and 8
Mental Distress using the Kessler Psychological Distress Scale (K-6)
时间窗: Time Frame:12 months post intervention
Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Self-Esteem using the Rosenberg Self-esteem Scale
时间窗: Time Frame:12 months post intervention
Minimum score 10 and a maximum score of 40. Investigators will reverse code items 3,5,8,9 and 10 . Higher scores indicate high levels of self-esteem (better outcome)
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
时间窗: Time Frame: 12 months post intervention
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
World Health Organisation- Five Well-Being Index (WHO-5)
时间窗: Time Frame: 12 months post intervention
Minimum score of 0 and a maximum of 25. Higher scores mean better wellbeing (better outcome). Scores are transformed to 0-100 (by multiplying by 4.
次要结局
- Business Performance 3(Time Frame: 12 months post intervention)
- Intimate Partner Violence 1(Time Frame: 12 months post intervention)
- Business Performance 2(Time Frame: 12 months post intervention)
- Business Performance 1(Time Frame: 12 months post intervention)
- Intimate Partner Violence 2(Time Frame: 12 months post intervention)