Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Emotion Regulation; Mental Stress; Violence, Gender-Based; Stress, Job; Economic Problems
• Intervention / Treatment: Behavioral: Stress managment

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adiam Hagos Hailemicheal, MSc; Phone Number: 7038431640; Email: ahailemicheal@worldbank.org
• Study Contact Backup: Name: Medhin Selamu Tegegn, PhD; Phone Number: +251919372313; Email: medhins10@gmail.com

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Recruiting
    • Policy Studies Institute
    • Contact: Medhin Selamu Tegegn, PhD; Phone Number: +251919372313; Email: medhins10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: World Bank
• Collaborators: Addis Ababa University; Ethiopian Medical Association; Policy Studies Institute
• Investigators: Principal Investigator: Naira Kalra, PhD, World Bank; Principal Investigator: Kassahun Habtamu Mekonnen, PhD, Addis Ababa University; Principal Investigator: Adiam Hagos Hailemicheal, MSc, World Bank; Principal Investigator: Medhin Selamu Tegegn, PhD, Addis Ababa University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Intimate Partner Violence; Psychological Wellbeing; Stress Managment; Business Performance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Occupational Diseases; Stress, Psychological; Occupational Stress
• Other Study ID Numbers: DWMTS-Scaleup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Baseline survey - April, 2025; Follow up surveys - July, 2025

IPD Sharing Access Criteria

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:

1. the identification of the Principal Investigators,
2. the title of the survey (including country, acronym and year of implementation)
3. the survey reference number
4. the source and date of download

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No