Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mental Stress
- Sponsor
- World Bank
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Depression using the Patient Health Questionnaire (PHQ-9)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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: 1. 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, 2. Widen the geographical and contextual coverage, 3. Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them, 4. Capture the impact on intimate partner violence, 5. Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Depression using the Patient Health Questionnaire (PHQ-9)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)