Clinical trial NCT05208723: Addressing Stress Amongst Female Entrepreneurs in Addis Ababa, Ethiopia: a Pilot Study
Official title: Stress and Emotion Management Training for Female Entrepreneurs in Ethiopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Emotion Regulation
Social Psychology
Economic Problems
Mental Stress
Keywords: Stress management
Economic benefits
Mental health
Lead sponsor: World Bank
Sponsor class: OTHER
Collaborators: name: Ethiopian Medical Association
name: Addis Ababa University
name: PSI Ethiopia
First posted: 2022-01-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants are randomized to intervention or control group
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mental Distress using the Kessler Psychological Distress Scale (K-6)
timeFrame: 4-6 weeks post intervention
measure: Mental Distress using the Kessler Psychological Distress Scale (K-6)
timeFrame: 6-9 months post intervention
measure: Depression using the Patient Health Questionnaire (PHQ-9)
timeFrame: 4-6 weeks post intervention
measure: Depression using the Patient Health Questionnaire (PHQ-9)
timeFrame: 6-9 months post intervention
measure: Stress using the Perceived Stress Scale
timeFrame: 4-6 weeks post intervention
measure: Stress using the Perceived Stress Scale
timeFrame: 6-9 months post intervention
measure: Self-reported Business outcomes
timeFrame: 6-9 months post intervention
Secondary outcomes:
measure: Self-reported Business outcomes
timeFrame: 4-6 weeks post intervention
measure: Self-reported Business Closure
timeFrame: 4-6 weeks post intervention
measure: Self-reported Business Closure
timeFrame: 6-9 months post intervention
measure: Self-reported number of recent hires
timeFrame: 4-6 weeks post intervention
measure: Self-reported number of employees
timeFrame: 6-9 months post intervention
measure: Self-Esteem using the Rosenberg Self-esteem Scale
timeFrame: 4-6 weeks post intervention
measure: Self-Esteem using the Rosenberg Self-esteem Scale
timeFrame: 6-9 months post intervention
measure: World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: 4-6 weeks post intervention
measure: World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: 6-9 months post intervention
measure: Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
timeFrame: 6-9 months post intervention
measure: Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)
timeFrame: 4-6 weeks post intervention
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: PSI and World Bank, Ethiopia
Study officials:
affiliation: World Bank
name: Naira Kalra, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Adiam Hailemicheal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University
name: Kassahun Habtamu Mekonnen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of health science, Addis Ababa University, Ethiopia
name: Medhin Selamu Tegegn, PhD
role: PRINCIPAL_INVESTIGATOR
References: