Clinical trial NCT05888272: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Stress
Stress
Stress, Job
Emotion Regulation
Violence, Gender-Based
Economic Problems
Keywords: Stress Managment
Psychological Wellbeing
Business Performance
Intimate Partner Violence
Lead sponsor: World Bank
Sponsor class: OTHER
Collaborators: name: Ethiopian Medical Association
name: Policy Studies Institute
name: Addis Ababa University
First posted: 2023-06-05
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Mental Distress using the Kessler Psychological Distress Scale (K-6)
timeFrame: Time Frame: 4-6 weeks post intervention
measure: Mental Distress using the Kessler Psychological Distress Scale (K-6)
timeFrame: Time Frame:12 months post intervention
measure: Depression using the Patient Health Questionnaire (PHQ-9)
timeFrame: Time Frame: 4-6 weeks post intervention
measure: Depression using the Patient Health Questionnaire (PHQ-9)
timeFrame: Time Frame: 12 months post intervention
measure: Stress using the Perceived Stress Scale
timeFrame: Time Frame: 4-6 weeks post intervention
measure: Stress using the Perceived Stress Scale
timeFrame: Time Frame: 12 months post intervention
measure: Self-Esteem using the Rosenberg Self-esteem Scale
timeFrame: Time Frame: 4-6 weeks post intervention
measure: Self-Esteem using the Rosenberg Self-esteem Scale
timeFrame: Time Frame:12 months post intervention
measure: World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: Time Frame: 4-6 weeks post intervention
measure: World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: Time Frame: 12 months post intervention
measure: Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
timeFrame: Time Frame: 4-6 weeks post intervention
measure: Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
timeFrame: Time Frame: 12 months post intervention
Secondary outcomes:
measure: Business Performance 1
timeFrame: Time Frame: 12 months post intervention
measure: Business Performance 2
timeFrame: Time Frame: 12 months post intervention
measure: Business Performance 3
timeFrame: Time Frame: 12 months post intervention
measure: Intimate Partner Violence 1
timeFrame: Time Frame: 12 months post intervention
measure: Intimate Partner Violence 2
timeFrame: Time Frame: 12 months post intervention
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Policy Studies Institute
Study officials:
affiliation: World Bank
name: Adiam Hagos Hailemicheal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Naira Kalra, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University
name: Medhin Selamu Tegegn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University
name: Kassahun Habtamu Mekonnen, PhD
role: PRINCIPAL_INVESTIGATOR
References: