Stress, Psychological Clinical Trial
— DWMTSOfficial title:
Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia
Verified date | February 2022 |
Source | World Bank |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | PSI and World Bank, Ethiopia | Addis Ababa |
Lead Sponsor | Collaborator |
---|---|
World Bank | Addis Ababa University, Ethiopian Medical Association, PSI Ethiopia |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Self-reported Business outcomes | Self-reported past month profits in local currency | 6-9 months post intervention | |
Secondary | Self-reported Business outcomes | Self-reported past month profits in local currency | 4-6 weeks post intervention | |
Secondary | Self-reported Business Closure | Self-reported business closure | 4-6 weeks post intervention | |
Secondary | Self-reported Business Closure | Self-reported business closure | 6-9 months post intervention | |
Secondary | Self-reported number of recent hires | Average self-reported number of employees hired in the past month | 4-6 weeks post intervention | |
Secondary | Self-reported number of employees | Average self-reported number of employees | 6-9 months post intervention | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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