Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia

Conditions
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Mental Stress, Stress, Stress, Job, Emotion Regulation, Violence, Gender-Based, Economic Problems

Intervention / Treatment
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* Behavioral: Stress managment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental - Stress Managment<br>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 | Behavioral: Stress managment<br>* 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.<br>* Other names: Doing What Matters in Times of Stress self-help hand book - the intervention does not involve any drugs.;|
| No Intervention: Waitlist Control<br>This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Managment, Psychological Wellbeing, Business Performance, Intimate Partner Violence