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| Name | Class |
|---|---|
| Ethiopian Medical Association | UNKNOWN |
| Policy Studies Institute | UNKNOWN |
| Addis Ababa University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - Stress Managment | Experimental | A locally adapted self-help guidebook originally developed by the World Health Organization (WHO), 'Doing what matters in times of stress' for managing disruptive emotions and psychological distress, will be delivered to women entrepreneurs at their residences, followed by 7 phone calls from a trained mental health helper to reinforce the materials over a 10-week period. The intervention is intended to help people manage their psychological distress associated with a range of adversities but is not intended for participants with severe mental health problems such as psychosis or imminent risk of suicide |
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| Waitlist Control | No Intervention | This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress managment | Behavioral | The Doing What Matters in Times of Stress self-help manual materials and lay helper scripts utilized in the study are rooted in the principles of Acceptance and Commitment Therapy (ACT). They are designed to improve psychological flexibility which refers to an individual's ability to adapt to changing situations, reallocate mental resources, shift perspectives, and balance competing priorities. The ACT approach teaches individuals how to manage challenging thoughts and emotions through mindfulness techniques, while also guiding them to live in alignment with their personal values. |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Distress using the Kessler Psychological Distress Scale (K-6) | Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome) | Time Frame: 4-6 weeks post intervention |
| Mental Distress using the Kessler Psychological Distress Scale (K-6) | Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome) | Time Frame:12 months post intervention |
| Depression using the Patient Health Questionnaire (PHQ-9) | Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome). | Time Frame: 4-6 weeks post intervention |
| Depression using the Patient Health Questionnaire (PHQ-9) | Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome). | Time Frame: 12 months post intervention |
| Stress using the Perceived Stress Scale | 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 | Time Frame: 4-6 weeks post intervention |
| Stress using the Perceived Stress Scale | 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 | Time Frame: 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Business Performance 1 | Monthly Profits | Time Frame: 12 months post intervention |
| Business Performance 2 | Monthly Sales | Time Frame: 12 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
Identifying as women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adiam Hagos Hailemicheal, MSc | Contact | 7038431640 | ahailemicheal@worldbank.org | |
| Medhin Selamu Tegegn, PhD | Contact | +251919372313 | medhins10@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adiam Hagos Hailemicheal, MSc | World Bank | Principal Investigator |
| Naira Kalra, PhD | World Bank | Principal Investigator |
| Medhin Selamu Tegegn, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policy Studies Institute | Recruiting | Addis Ababa | Ethiopia |
The research team will share de-identified IPD two years after the completion of each survey based after securing clearance from the Ethiopian Public Health Asssociations IRB.
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Baseline survey - April, 2025; Follow up surveys - July, 2025
The data will be publicly available on the World Bank's microdata website. Use of the dataset must be acknowledged using a citation which would include:
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000073397 | Occupational Stress |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009784 | Occupational Diseases |
| D000068356 | Self-Control |
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Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
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Randomized using computer-generated randomization at one point in time.
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| Self-Esteem using the Rosenberg Self-esteem Scale | 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) | Time Frame: 4-6 weeks post intervention |
| Self-Esteem using the Rosenberg Self-esteem Scale | 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) | Time Frame:12 months post intervention |
| World Health Organisation- Five Well-Being Index (WHO-5) | 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. | Time Frame: 4-6 weeks post intervention |
| World Health Organisation- Five Well-Being Index (WHO-5) | 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. | Time Frame: 12 months post intervention |
| Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version) | Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome) | Time Frame: 4-6 weeks post intervention |
| Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version) | Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome) | Time Frame: 12 months post intervention |
| Business Performance 3 | Business size measured using number of employees | Time Frame: 12 months post intervention |
| Intimate Partner Violence 1 | Experience of at least one form of Physical Violence measured using the Demographic and Health Survey module for the experience of physical intimate partner violence. | Time Frame: 12 months post intervention |
| Intimate Partner Violence 2 | Experience of at least one form of Emotional Violence measured using the Demographic and Health Survey module for the experience of emotional intimate partner violence. | Time Frame: 12 months post intervention |
| Addis Ababa University |
| Principal Investigator |
| Kassahun Habtamu Mekonnen, PhD | Addis Ababa University | Principal Investigator |
| D012919 |
| Social Behavior |