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Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Primary Purpose

Mental Stress, Stress, Stress, Job

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Stress managment
Sponsored by
World Bank
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Stress focused on measuring Stress Managment, Psychological Wellbeing, Business Performance, Intimate Partner Violence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Policy Studies InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental - Stress Managment

Waitlist Control

Arm Description

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

This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest.

Outcomes

Primary Outcome Measures

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)
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)
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).
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).
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
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
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)
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)
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.
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.
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)
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)

Secondary Outcome Measures

Business Performance 1
Monthly Profits
Business Performance 2
Monthly Sales
Business Performance 3
Business size measured using number of employees
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.
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.

Full Information

First Posted
April 15, 2023
Last Updated
May 23, 2023
Sponsor
World Bank
Collaborators
Ethiopian Medical Association, Policy Studies Institute, Addis Ababa University
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1. Study Identification

Unique Protocol Identification Number
NCT05888272
Brief Title
Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up
Official Title
Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
World Bank
Collaborators
Ethiopian Medical Association, Policy Studies Institute, Addis Ababa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress, Stress, Stress, Job, Emotion Regulation, Violence, Gender-Based, Economic Problems
Keywords
Stress Managment, Psychological Wellbeing, Business Performance, Intimate Partner Violence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
Masking
Outcomes Assessor
Masking Description
Randomized using computer-generated randomization at one point in time.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental - Stress Managment
Arm Type
Experimental
Arm Description
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
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest.
Intervention Type
Behavioral
Intervention Name(s)
Stress managment
Other Intervention Name(s)
Doing What Matters in Times of Stress self-help hand book - the intervention does not involve any drugs.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mental Distress using the Kessler Psychological Distress Scale (K-6)
Description
Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Time Frame
Time Frame: 4-6 weeks post intervention
Title
Mental Distress using the Kessler Psychological Distress Scale (K-6)
Description
Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Time Frame
Time Frame:12 months post intervention
Title
Depression using the Patient Health Questionnaire (PHQ-9)
Description
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Time Frame
Time Frame: 4-6 weeks post intervention
Title
Depression using the Patient Health Questionnaire (PHQ-9)
Description
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Time Frame
Time Frame: 12 months post intervention
Title
Stress using the Perceived Stress Scale
Description
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
Time Frame: 4-6 weeks post intervention
Title
Stress using the Perceived Stress Scale
Description
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
Time Frame: 12 months post intervention
Title
Self-Esteem using the Rosenberg Self-esteem Scale
Description
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
Time Frame: 4-6 weeks post intervention
Title
Self-Esteem using the Rosenberg Self-esteem Scale
Description
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
Time Frame:12 months post intervention
Title
World Health Organisation- Five Well-Being Index (WHO-5)
Description
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
Time Frame: 4-6 weeks post intervention
Title
World Health Organisation- Five Well-Being Index (WHO-5)
Description
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
Time Frame: 12 months post intervention
Title
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Description
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
Time Frame
Time Frame: 4-6 weeks post intervention
Title
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Description
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
Time Frame
Time Frame: 12 months post intervention
Secondary Outcome Measure Information:
Title
Business Performance 1
Description
Monthly Profits
Time Frame
Time Frame: 12 months post intervention
Title
Business Performance 2
Description
Monthly Sales
Time Frame
Time Frame: 12 months post intervention
Title
Business Performance 3
Description
Business size measured using number of employees
Time Frame
Time Frame: 12 months post intervention
Title
Intimate Partner Violence 1
Description
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
Time Frame: 12 months post intervention
Title
Intimate Partner Violence 2
Description
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
Time Frame: 12 months post intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identifying as women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adiam Hagos Hailemicheal, MSc
Phone
7038431640
Email
ahailemicheal@worldbank.org
First Name & Middle Initial & Last Name or Official Title & Degree
Medhin Selamu Tegegn, PhD
Phone
+251919372313
Email
medhins10@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adiam Hagos Hailemicheal, MSc
Organizational Affiliation
World Bank
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naira Kalra, PhD
Organizational Affiliation
World Bank
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medhin Selamu Tegegn, PhD
Organizational Affiliation
Addis Ababa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kassahun Habtamu Mekonnen, PhD
Organizational Affiliation
Addis Ababa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policy Studies Institute
City
Addis Ababa
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medhin Selamu Tegegn, PhD
Phone
+251919372313
Email
medhins10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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: the identification of the Principal Investigators, the title of the survey (including country, acronym and year of implementation) the survey reference number the source and date of download
IPD Sharing URL
https://www.worldbank.org/en/programs/africa-gender-innovation-lab/brief/africa-gender-innovation-lab-data

Learn more about this trial

Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

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