Addressing Stress Amongst Female Entrepreneurs in Addis Ababa, Ethiopia: a Pilot Study

Not Applicable

• Conditions: Stress, Psychological; Economic Problems; Emotion Regulation; Social Psychology; Mental Stress
• Interventions: Behavioral: Stress and emotion management

• Registration Number: NCT05208723
• Lead Sponsor: World Bank

Brief Summary

The overall objective of this study is to evaluate the impact of the "Doing What Matters in Times of Stress Guided Self-Help" handbook along with lay helper session on managing stress and emotion on mental distress and well-being. If successful, the study will assess its impact on business performance among women entrepreneurs in Ethiopia.

Detailed Description

The overall objective of this study is to evaluate the impact of the "Doing What Matters in Times of Stress Guided Self-Help Manual" on mental distress and if successful, see its impact on business performance among women entrepreneurs in Ethiopia. The study will be conducted in Addis Ababa, Ethiopia. A pilot randomized controlled trial (RCT) will be conducted to investigate the impact of the "Doing What Matters in Times of Stress Guided Self-Help Manual" intervention to reduce psychological distress and functional impairment among women entrepreneurs in Ethiopia. The investigators will screen approximately1200 women over the phone and identify 200 eligible women for the study. An in-person baseline survey will be conducted with the 200 eligible women and the participants will be randomized (using computer generated randomization) to either the doing what matters in times of stress self-help manual intervention (n=100) or wait list control (n=100). This will be followed by 6 phone-based sessions over 6-8 weeks to review handbook materials for the intervention group only. After six weeks, phone-based follow-up survey will be conducted with participants in both the intervention and control groups. If the intervention is found to be effective in reducing distress or stress at follow-up assessment, then the baseline survey will be repeated at 6-9 months post intervention both for the intervention and control group participants. Additionally, based on findings from the pilot study a larger sample of participants will be screened and enrolled (approximately 1000 women) and randomized to the intervention or wait-list control arm to be followed up at 6-9 months post intervention. The primary outcomes for this study will be psychological distress. Participants' performance on their businesses and self-esteem will be secondary outcomes for the study. A generalized linear model with appropriate statistical specifications and accounting for baseline values and any imbalanced variables at baseline (where available) will be used to analyze the data.

Study Timeline

• Study Start: 2021-07-17
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Age ≥18;
• Women entrepreneurs who obtained loan or business skills training from WEDP;
• Those who have plan to live in Addis Ababa in the next six months;
• Those who can read and speak Amharic and can understand the study questionnaire;
• Those who have 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 limitation to understand the study questionnaire;
• Those who have not capacity to provide informed consent;
• Do not own a mobile phone;
• Not interested in receiving the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress and emotion management	Stress and emotion management	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 female entrepreneurs at their residence, followed by 5-6 phone calls from a trained mental health helper to reinforce the materials over a 6-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.

Primary Outcome Measures

Name	Time	Method
Mental Distress using the Kessler Psychological Distress Scale (K-6)	6-9 months post intervention	Minimum value of 0 and a maximum score of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Stress using the Perceived Stress Scale	6-9 months post intervention	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
Depression using the Patient Health Questionnaire (PHQ-9)	6-9 months post intervention	Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Self-reported Business outcomes	6-9 months post intervention	Self-reported past month profits in local currency

Secondary Outcome Measures

Name	Time	Method
Self-reported number of employees	6-9 months post intervention	Average self-reported number of employees
Self-Esteem using the Rosenberg Self-esteem Scale	6-9 months post intervention	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-reported number of recent hires	4-6 weeks post intervention	Average self-reported number of employees hired in the past month
Self-reported Business outcomes	4-6 weeks post intervention	Self-reported past month profits in local currency
Self-reported Business Closure	6-9 months post intervention	Self-reported business closure
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)	4-6 weeks post intervention	Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
World Health Organisation- Five Well-Being Index (WHO-5)	6-9 months post intervention	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.

Trial Locations

Locations (1)

PSI and World Bank, Ethiopia; 🇪🇹 Addis Ababa, Ethiopia