Stress Clinical Trial - Addressing Stress Among Women Entrepreneurs in

Status Recruiting

Clinical 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.

Clinical Trial 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: 1. 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, 2. Widen the geographical and contextual coverage, 3. Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them, 4. Capture the impact on intimate partner violence, 5. 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05888272
Study type	Interventional
Source	World Bank
Contact	Adiam Hagos Hailemicheal, MSc
Phone	7038431640
Email	ahailemicheal@worldbank.org
Status	Recruiting
Phase	N/A
Start date	April 4, 2023
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05130944` - Feasibility of Community Psychosocial Intervention for Women	N/A
Recruiting	`NCT06079853` - Nurse Suicide: Physiologic Sleep Health Promotion Trial	N/A
Completed	`NCT05881681` - A Mindfulness Approach to UA for Afro-descendants	N/A
Recruiting	`NCT05449002` - Digital Single Session Intervention for Youth Mental Health	N/A
Recruiting	`NCT04038190` - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course	Phase 2
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Active, not recruiting	`NCT05998161` - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout	N/A
Completed	`NCT03728062` - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence	N/A
Terminated	`NCT04367636` - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19	N/A
Recruiting	`NCT06002074` - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Completed	`NCT05245409` - Stress, EEG, ECG, and Chiropractic	N/A
Completed	`NCT04722367` - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection	N/A
Recruiting	`NCT06273228` - Parenting Young Children in Pediatrics	N/A
Completed	`NCT06057883` - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females	Phase 2
Completed	`NCT05312749` - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students	N/A
Completed	`NCT05063305` - Probiotics, Immunity, Stress, and QofL	N/A
Completed	`NCT05623826` - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager	N/A
Completed	`NCT04013451` - The Kiss of Kindness Study II	N/A
Withdrawn	`NCT03749278` - Latina Friends Motivating the Soul (ALMA)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms