Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

World Bank

Status: Enrolling

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

Treatments: Behavioral: Stress managment

Study type: Interventional

Funder types: Other

Identifiers

NCT05888272

DWMTS-Scaleup

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Experimental - Stress Managment

Experimental group

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

Treatment:

Behavioral: Stress managment

Waitlist Control

No Intervention group

Description:

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