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

Stress, Psychological Clinical Trial

— DWMTS  

Official title:

Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05208723
• Other study ID #: DWMTS
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: World Bank
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. If successful, the study will assess its impact on business performance among women entrepreneurs in Ethiopia.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Economic Problems
• Emotion Regulation
• Mental Stress
• Social Psychology
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Ethiopia	PSI and World Bank, Ethiopia	Addis Ababa

Sponsors (4)

Lead Sponsor	Collaborator
World Bank	Addis Ababa University, Ethiopian Medical Association, PSI Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

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