Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mental Distress using the Kessler Psychological Distress Scale (K-6)
研究概览
简要总结
The overall objective of this study is to evaluate the impact of the "Doing What Matters in Times of Stress Guided Self-Help" handbook along with lay helper session on managing stress and emotion on mental distress and well-being. If successful, the study will assess its impact on business performance among women entrepreneurs in Ethiopia.
详细描述
The overall objective of this study is to evaluate the impact of the "Doing What Matters in Times of Stress Guided Self-Help Manual" on mental distress and if successful, see its impact on business performance among women entrepreneurs in Ethiopia. The study will be conducted in Addis Ababa, Ethiopia. A pilot randomized controlled trial (RCT) will be conducted to investigate the impact of the "Doing What Matters in Times of Stress Guided Self-Help Manual" intervention to reduce psychological distress and functional impairment among women entrepreneurs in Ethiopia. The investigators will screen approximately1200 women over the phone and identify 200 eligible women for the study. An in-person baseline survey will be conducted with the 200 eligible women and the participants will be randomized (using computer generated randomization) to either the doing what matters in times of stress self-help manual intervention (n=100) or wait list control (n=100). This will be followed by 6 phone-based sessions over 6-8 weeks to review handbook materials for the intervention group only. After six weeks, phone-based follow-up survey will be conducted with participants in both the intervention and control groups. If the intervention is found to be effective in reducing distress or stress at follow-up assessment, then the baseline survey will be repeated at 6-9 months post intervention both for the intervention and control group participants. Additionally, based on findings from the pilot study a larger sample of participants will be screened and enrolled (approximately 1000 women) and randomized to the intervention or wait-list control arm to be followed up at 6-9 months post intervention. The primary outcomes for this study will be psychological distress. Participants' performance on their businesses and self-esteem will be secondary outcomes for the study. A generalized linear model with appropriate statistical specifications and accounting for baseline values and any imbalanced variables at baseline (where available) will be used to analyze the data.
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 (Investigator)
盲法说明
Randomized using computer generated randomization at one point in time by an independent researcher
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
- •Women entrepreneurs who obtained loan or business skills training from WEDP;
- •Those who have plan to live in Addis Ababa in the next six months;
- •Those who can read and speak Amharic and can understand the study questionnaire;
- •Those who have 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 limitation to understand the study questionnaire;
- •Those who have not capacity to provide informed consent;
- •Do not own a mobile phone;
- •Not interested in receiving the intervention
结局指标
主要结局
Mental Distress using the Kessler Psychological Distress Scale (K-6)
时间窗: 6-9 months post intervention
Minimum value of 0 and a maximum score of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Stress using the Perceived Stress Scale
时间窗: 6-9 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
Depression using the Patient Health Questionnaire (PHQ-9)
时间窗: 6-9 months post intervention
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Self-reported Business outcomes
时间窗: 6-9 months post intervention
Self-reported past month profits in local currency
次要结局
- Self-Esteem using the Rosenberg Self-esteem Scale(6-9 months post intervention)
- Self-reported number of recent hires(4-6 weeks post intervention)
- Self-reported number of employees(6-9 months post intervention)
- Self-reported Business outcomes(4-6 weeks post intervention)
- Self-reported Business Closure(6-9 months post intervention)
- Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)(4-6 weeks post intervention)
- World Health Organisation- Five Well-Being Index (WHO-5)(6-9 months post intervention)