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

Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Psychological; Emotion Regulation; Social Psychology; Mental Stress; Economic Problems
• Intervention / Treatment: Behavioral: Stress and emotion management

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • PSI and World Bank, Ethiopia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Stress and emotion management; The handbook materials and lay helper scripts are based on principles of Acceptance and Commitment Therapy (ACT), and aims to enhance psychological flexibility. Psychological flexibility reflects how a person adapts to fluctuating situational demands, reconfigures mental resources, shifts perspective, and balances competing needs. ACT teaches alternative methods to accommodate difficult thoughts and feelings, primarily through mindfulness techniques. At the same time, ACT also focuses on guiding participants to live in ways consistent with their personal values.; Other Names: Doing what matters in times of Stress; Acceptance and Commitment Therapy (ACT)
No Intervention: Control group; No intervention. May receive intervention post study if findings are indicative of any benefit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4-6 weeks post intervention
Mental Distress using the Kessler Psychological Distress Scale (K-6)	Minimum value of 0 and a maximum score of 24. Higher scores indicate high levels of psychological distress (worse outcome)	6-9 months post intervention
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).	4-6 weeks post intervention
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).	6-9 months post intervention
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	4-6 weeks post intervention
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	6-9 months post intervention
Self-reported Business outcomes	Self-reported past month profits in local currency	6-9 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Business outcomes	Self-reported past month profits in local currency	4-6 weeks post intervention
Self-reported Business Closure	Self-reported business closure	4-6 weeks post intervention
Self-reported Business Closure	Self-reported business closure	6-9 months post intervention
Self-reported number of recent hires	Average self-reported number of employees hired in the past month	4-6 weeks post intervention
Self-reported number of employees	Average self-reported number of employees	6-9 months post intervention
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)	4-6 weeks post intervention
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)	6-9 months post intervention
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.	4-6 weeks post intervention
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.	6-9 months post intervention
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)	6-9 months post intervention
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)	4-6 weeks post intervention

Collaborators and Investigators

• Sponsor: World Bank
• Collaborators: Addis Ababa University; Ethiopian Medical Association; PSI Ethiopia
• Investigators: Principal Investigator: Naira Kalra, PhD, World Bank; Principal Investigator: Adiam Hailemicheal, MSc, World Bank; Principal Investigator: Kassahun Habtamu Mekonnen, PhD, Addis Ababa University; Principal Investigator: Medhin Selamu Tegegn, PhD, College of health science, Addis Ababa University, Ethiopia

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Mental health; Stress management; Economic benefits
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: DWMTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All unidentified IPD that underlie results in a publication will be shared if doing so is approved by the Institutional Review Board and clears privacy and security requirements set by the World Bank microdata portal.
• IPD Sharing Time Frame: Post study in 2023. Will be shared for at least 2 years.

IPD Sharing Access Criteria

Publicly available. Use of the dataset must be acknowledged using a citation which would include:

• the Identification of the Primary Investigator
• the title of the survey (including country, acronym and year of implementation)
• the survey reference number
• the source and date of download

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No