Stress, PsychologicalDWMTSNCT05208723
Addressing Stress Amongst Female Entrepreneurs in Addis Ababa, Ethiopia: a Pilot Study
A study testing Stress and emotion management in people with Stress, Psychological and Emotion Regulation, run by World Bank at 1 site in Ethiopia.
Trial 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. 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
- Stress, Psychological, Emotion Regulation, Social Psychology
- What is being tested?
- Stress and emotion management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEthiopia
- Study dates
- 17 Jul 2021to 31 Dec 2023
- 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;
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological, Emotion Regulation, Social Psychology, Economic Problems, Mental Stress
- Being tested
- Stress and emotion management
- Keywords
- Stress management, Economic benefits, Mental health
- Medical subject headings
- Stress, Psychological, Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress and emotion managementBehavioural
Also called Doing what matters in times of Stress, Acceptance and Commitment Therapy (ACT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress and emotion management | 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 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. Receives: Behavioral: Stress and emotion management |
| Control group | No intervention | No intervention. May receive intervention post study if findings are indicative of any benefit. |
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: 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)
Measured: 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).
Measured: 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: 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
Measured: 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: 6-9 months post intervention
Self-reported Business outcomes
Self-reported past month profits in local currency
Measured: 6-9 months post intervention
Secondary outcomes (11)
Self-reported Business outcomes
Self-reported past month profits in local currency
Measured: 4-6 weeks post intervention
Self-reported Business Closure
Self-reported business closure
Measured: 4-6 weeks post intervention
Self-reported Business Closure
Self-reported business closure
Measured: 6-9 months post intervention
Self-reported number of recent hires
Average self-reported number of employees hired in the past month
Measured: 4-6 weeks post intervention
Self-reported number of employees
Average self-reported number of employees
Measured: 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)
Measured: 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: 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.
Measured: 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: 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)
Measured: 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)
Measured: 4-6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start17 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Enrolled participants are randomized to intervention or control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Medical Association, Addis Ababa University, PSI Ethiopia
- Responsible party
- Sponsor
- Investigators
- Naira Kalra, PhD, Principal investigator, World BankAdiam Hailemicheal, MSc, Principal investigator, World BankKassahun Habtamu Mekonnen, PhD, Principal investigator, Addis Ababa UniversityMedhin Selamu Tegegn, PhD, Principal investigator, College of health science, Addis Ababa University, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208723
- Sponsor's protocol ID
- DWMTS
- Acronym
- DWMTS
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia
- ClinicalTrials.gov ID
- NCT05208723
- Acronym / sponsor ID
- DWMTS / DWMTS
- Conditions
- Stress, Psychological, Emotion Regulation, Social Psychology, Economic Problems, Mental Stress
- Keywords
- Stress management, Economic benefits, Mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- Ethiopian Medical Association, Addis Ababa University, PSI Ethiopia
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jan 2022 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Enrolled participants are randomized to intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Stress and emotion management | Experimental | Behavioral: Stress and emotion managementA 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. |
| Control group | No intervention | –No intervention. May receive intervention post study if findings are indicative of any benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
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 and emotion managementAlso: Doing what matters in times of Stress, Acceptance and Commitment Therapy (ACT)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. | Behavioural | Stress and emotion management |
Primary outcome
Mental Distress using the Kessler Psychological Distress Scale (K-6)
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: 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)
Depression using the Patient Health Questionnaire (PHQ-9)
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: 6-9 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: 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: 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
Self-reported Business outcomes
Time frame: 6-9 months post intervention
Self-reported past month profits in local currency
11 secondary outcomes
Self-reported Business outcomes
Time frame: 4-6 weeks post intervention
Self-reported Business Closure
Time frame: 4-6 weeks post intervention
Self-reported Business Closure
Time frame: 6-9 months post intervention
Self-reported number of recent hires
Time frame: 4-6 weeks post intervention
Self-reported number of employees
Time frame: 6-9 months post intervention
Self-Esteem using the Rosenberg Self-esteem Scale
Time frame: 4-6 weeks post intervention
Self-Esteem using the Rosenberg Self-esteem Scale
Time frame: 6-9 months post intervention
World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: 4-6 weeks post intervention
World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: 6-9 months post intervention
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Time frame: 6-9 months post intervention
Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
Time frame: 4-6 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
Naira Kalra, PhD principal investigator
World Bank
Adiam Hailemicheal, MSc principal investigator
World Bank
Kassahun Habtamu Mekonnen, 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 and emotion management in people with Stress, Psychological and Emotion Regulation, 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 6 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 15 Feb 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 4-6 weeks post intervention). The study lists 7 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 15 Feb 2022.