Mental StressNCT05888272
Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up
A study testing Stress managment in people with Mental Stress and Stress, run by World Bank at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Stress, Stress, Stress, Job
- What is being tested?
- Stress managment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEthiopia
- Study dates
- 4 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Policy Studies Institute
Addis Ababa
Medhin Selamu Tegegn, PhD, +251919372313, medhins10@gmail.com
About this study
Official title: Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia
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.
Read the 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:
- 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,
- Widen the geographical and contextual coverage,
- Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them,
- Capture the impact on intimate partner violence,
- Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.
- Conditions
- Mental Stress, Stress, Stress, Job, Emotion Regulation, Violence, Gender-Based, Economic Problems
- Being tested
- Stress managment
- Keywords
- Stress Managment, Psychological Wellbeing, Business Performance, Intimate Partner Violence
- Medical subject headings
- Stress, Psychological, Occupational Stress, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress managmentBehavioural
Also called Doing What Matters in Times of Stress self-help hand book - the intervention does not involve any drugs.
The Doing What Matters in Times of Stress self-help manual materials and lay helper scripts utilized in the study are rooted in the principles of Acceptance and Commitment Therapy (ACT). They are designed to improve psychological flexibility which refers to an individual's ability to adapt to changing situations, reallocate mental resources, shift perspectives, and balance competing priorities. The ACT approach teaches individuals how to manage challenging thoughts and emotions through mindfulness techniques, while also guiding them to live in alignment with their personal values.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Stress Managment | Experimental | 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 women entrepreneurs at their residences, followed by 7 phone calls from a trained mental health helper to reinforce the materials over a 10-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 Receives: Behavioral: Stress managment |
| Waitlist Control | No intervention | This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time Frame: 4-6 weeks post intervention
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)
Measured: Time Frame:12 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).
Measured: Time Frame: 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).
Measured: Time Frame: 12 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
Measured: Time Frame: 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
Measured: Time Frame: 12 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)
Measured: Time Frame: 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)
Measured: Time Frame:12 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.
Measured: Time Frame: 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.
Measured: Time Frame: 12 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)
Measured: Time Frame: 4-6 weeks 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)
Measured: Time Frame: 12 months post intervention
Secondary outcomes (5)
Business Performance 1
Monthly Profits
Measured: Time Frame: 12 months post intervention
Business Performance 2
Monthly Sales
Measured: Time Frame: 12 months post intervention
Business Performance 3
Business size measured using number of employees
Measured: Time Frame: 12 months post intervention
Intimate Partner Violence 1
Experience of at least one form of Physical Violence measured using the Demographic and Health Survey module for the experience of physical intimate partner violence.
Measured: Time Frame: 12 months post intervention
Intimate Partner Violence 2
Experience of at least one form of Emotional Violence measured using the Demographic and Health Survey module for the experience of emotional intimate partner violence.
Measured: Time Frame: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start4 Apr 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Medical Association, Policy Studies Institute, Addis Ababa University
- Responsible party
- Sponsor
- Investigators
- Adiam Hagos Hailemicheal, MSc, Principal investigator, World BankNaira Kalra, PhD, Principal investigator, World BankMedhin Selamu Tegegn, PhD, Principal investigator, Addis Ababa UniversityKassahun Habtamu Mekonnen, PhD, Principal investigator, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888272
- Sponsor's protocol ID
- DWMTS-Scaleup
- Status last verified
- May 2023
- First submitted
- 15 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share de-identified IPD two years after the completion of each survey based after securing clearance from the Ethiopian Public Health Asssociations IRB.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Stress Management Training on the Business Performance of Women Entrepreneurs in Ethiopia
- ClinicalTrials.gov ID
- NCT05888272
- Acronym / sponsor ID
- DWMTS-Scaleup
- Conditions
- Mental Stress, Stress, Stress, Job, Emotion Regulation, Violence, Gender-Based, Economic Problems
- Keywords
- Stress Managment, Psychological Wellbeing, Business Performance, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- Ethiopian Medical Association, Policy Studies Institute, Addis Ababa University
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- Widen the geographical and contextual coverage,
- Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them,
- Capture the impact on intimate partner violence,
- Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Stress Managment | Experimental | Behavioral: Stress managmentA 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 women entrepreneurs at their residences, followed by 7 phone calls from a trained mental health helper to reinforce the materials over a 10-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 |
| Waitlist Control | No intervention | –This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress managmentAlso: Doing What Matters in Times of Stress self-help hand book - the intervention does not involve any drugs.The Doing What Matters in Times of Stress self-help manual materials and lay helper scripts utilized in the study are rooted in the principles of Acceptance and Commitment Therapy (ACT). They are designed to improve psychological flexibility which refers to an individual's ability to adapt to changing situations, reallocate mental resources, shift perspectives, and balance competing priorities. The ACT approach teaches individuals how to manage challenging thoughts and emotions through mindfulness techniques, while also guiding them to live in alignment with their personal values. | Behavioural | Experimental - Stress Managment |
Primary outcome
Mental Distress using the Kessler Psychological Distress Scale (K-6)
Time frame: Time Frame: 4-6 weeks post intervention
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)
Time frame: Time Frame:12 months post intervention
Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)
Depression using the Patient Health Questionnaire (PHQ-9)
Time frame: Time Frame: 4-6 weeks post intervention
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)
Time frame: Time Frame: 12 months post intervention
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
Time frame: Time Frame: 4-6 weeks 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
Stress using the Perceived Stress Scale
Time frame: Time Frame: 12 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
Self-Esteem using the Rosenberg Self-esteem Scale
Time frame: Time Frame: 4-6 weeks 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-Esteem using the Rosenberg Self-esteem Scale
Time frame: Time Frame:12 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)
World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: Time Frame: 4-6 weeks 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.
World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: Time Frame: 12 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.
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Time frame: Time Frame: 4-6 weeks post intervention
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)
Time frame: Time Frame: 12 months post intervention
Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)
5 secondary outcomes
Business Performance 1
Time frame: Time Frame: 12 months post intervention
Business Performance 2
Time frame: Time Frame: 12 months post intervention
Business Performance 3
Time frame: Time Frame: 12 months post intervention
Intimate Partner Violence 1
Time frame: Time Frame: 12 months post intervention
Intimate Partner Violence 2
Time frame: Time Frame: 12 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes. The research team will share de-identified IPD two years after the completion of each survey based after securing clearance from the Ethiopian Public Health Asssociations IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adiam Hagos Hailemicheal, MSc principal investigator
World Bank
Naira Kalra, PhD principal investigator
World Bank
Medhin Selamu Tegegn, PhD principal investigator
Addis Ababa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress managment in people with Mental Stress and Stress, run by World Bank at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adiam Hagos Hailemicheal, MSc (7038431640, ahailemicheal@worldbank.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Distress using the Kessler Psychological Distress Scale (K-6) (time frame: Time Frame: 4-6 weeks post intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.