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

World Bank

Status: Unknown

Conditions: Mental Stress; Emotion Regulation; Stress, Psychological; Economic Problems; Social Psychology

Treatments: Behavioral: Stress and emotion management

Study type: Interventional

Funder types: Other

Identifiers

NCT05208723

DWMTS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Stress and emotion management

Experimental group

Description:

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.

Treatment:

Behavioral: Stress and emotion management

Control group

No Intervention group

Description:

No intervention. May receive intervention post study if findings are indicative of any benefit.