Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Last updated: May 23, 2023
Sponsor: World Bank
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Emotional Processing

Treatment

Stress managment

Clinical Study ID

NCT05888272
DWMTS-Scaleup
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Stress managment
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Policy Studies Institute

    Addis Ababa,
    Ethiopia

    Active - Recruiting

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