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

Primary Purpose

Stress, Psychological, Emotion Regulation, Social Psychology

Status
Active
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Stress and emotion management
Sponsored by
World Bank
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Stress management, Economic benefits, Mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • PSI and World Bank, Ethiopia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stress and emotion management

Control group

Arm 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 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.

No intervention. May receive intervention post study if findings are indicative of any benefit.

Outcomes

Primary Outcome Measures

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)
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)
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).
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).
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
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
Self-reported Business outcomes
Self-reported past month profits in local currency

Secondary Outcome Measures

Self-reported Business outcomes
Self-reported past month profits in local currency
Self-reported Business Closure
Self-reported business closure
Self-reported Business Closure
Self-reported business closure
Self-reported number of recent hires
Average self-reported number of employees hired in the past month
Self-reported number of employees
Average self-reported number of employees
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)
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)
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.
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.
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)
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)

Full Information

First Posted
December 20, 2021
Last Updated
February 3, 2022
Sponsor
World Bank
Collaborators
Ethiopian Medical Association, Addis Ababa University, PSI Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT05208723
Brief Title
Addressing Stress Amongst Female Entrepreneurs in Addis Ababa, Ethiopia: a Pilot Study
Acronym
DWMTS
Official Title
Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
World Bank
Collaborators
Ethiopian Medical Association, Addis Ababa University, PSI Ethiopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Emotion Regulation, Social Psychology, Economic Problems, Mental Stress
Keywords
Stress management, Economic benefits, Mental health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled participants are randomized to intervention or control group
Masking
Investigator
Masking Description
Randomized using computer generated randomization at one point in time by an independent researcher
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress and emotion management
Arm Type
Experimental
Arm 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 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention. May receive intervention post study if findings are indicative of any benefit.
Intervention Type
Behavioral
Intervention Name(s)
Stress and emotion management
Other Intervention Name(s)
Doing what matters in times of Stress, Acceptance and Commitment Therapy (ACT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mental Distress using the Kessler Psychological Distress Scale (K-6)
Description
Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Time Frame
4-6 weeks post intervention
Title
Mental Distress using the Kessler Psychological Distress Scale (K-6)
Description
Minimum value of 0 and a maximum score of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Time Frame
6-9 months post intervention
Title
Depression using the Patient Health Questionnaire (PHQ-9)
Description
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Time Frame
4-6 weeks post intervention
Title
Depression using the Patient Health Questionnaire (PHQ-9)
Description
Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).
Time Frame
6-9 months post intervention
Title
Stress using the Perceived Stress Scale
Description
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
Time Frame
4-6 weeks post intervention
Title
Stress using the Perceived Stress Scale
Description
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
Time Frame
6-9 months post intervention
Title
Self-reported Business outcomes
Description
Self-reported past month profits in local currency
Time Frame
6-9 months post intervention
Secondary Outcome Measure Information:
Title
Self-reported Business outcomes
Description
Self-reported past month profits in local currency
Time Frame
4-6 weeks post intervention
Title
Self-reported Business Closure
Description
Self-reported business closure
Time Frame
4-6 weeks post intervention
Title
Self-reported Business Closure
Description
Self-reported business closure
Time Frame
6-9 months post intervention
Title
Self-reported number of recent hires
Description
Average self-reported number of employees hired in the past month
Time Frame
4-6 weeks post intervention
Title
Self-reported number of employees
Description
Average self-reported number of employees
Time Frame
6-9 months post intervention
Title
Self-Esteem using the Rosenberg Self-esteem Scale
Description
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)
Time Frame
4-6 weeks post intervention
Title
Self-Esteem using the Rosenberg Self-esteem Scale
Description
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)
Time Frame
6-9 months post intervention
Title
World Health Organisation- Five Well-Being Index (WHO-5)
Description
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.
Time Frame
4-6 weeks post intervention
Title
World Health Organisation- Five Well-Being Index (WHO-5)
Description
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.
Time Frame
6-9 months post intervention
Title
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Description
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
Time Frame
6-9 months post intervention
Title
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Description
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
Time Frame
4-6 weeks post intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
identifying as women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naira Kalra, PhD
Organizational Affiliation
World Bank
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adiam Hailemicheal, MSc
Organizational Affiliation
World Bank
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kassahun Habtamu Mekonnen, PhD
Organizational Affiliation
Addis Ababa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medhin Selamu Tegegn, PhD
Organizational Affiliation
College of health science, Addis Ababa University, Ethiopia
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSI and World Bank, Ethiopia
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.worldbank.org/en/programs/africa-gender-innovation-lab/brief/africa-gender-innovation-lab-data

Learn more about this trial

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

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