Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888272
• Other study ID #: DWMTS-Scaleup
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: World Bank
• Contact: Adiam Hagos Hailemicheal, MSc
• Phone: 7038431640
• Email: ahailemicheal[@]worldbank.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Economic Problems
• Emotion Regulation
• Mental Stress
• Occupational Stress
• Stress
• Stress, Psychological
• Violence, Gender-Based

Intervention

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.

Locations

Country	Name	City	State
Ethiopia	Policy Studies Institute	Addis Ababa

Sponsors (4)

Lead Sponsor	Collaborator
World Bank	Addis Ababa University, Ethiopian Medical Association, Policy Studies Institute

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Business Performance 1	Monthly Profits	Time Frame: 12 months post intervention
Secondary	Business Performance 2	Monthly Sales	Time Frame: 12 months post intervention
Secondary	Business Performance 3	Business size measured using number of employees	Time Frame: 12 months post intervention
Secondary	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
Secondary	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