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

NCT05208723 | Unknown

• 1 other identifier: DWMTS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stress management; Economic benefits; Mental health

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• Self-reported Business outcomes

  Self-reported past month profits in local currency

  6-9 months post intervention

Secondary Outcomes (11)

• Self-reported Business outcomes

  4-6 weeks post intervention

• Self-reported Business Closure

  4-6 weeks post intervention

• Self-reported Business Closure

  6-9 months post intervention

• Self-reported number of recent hires

  4-6 weeks post intervention

• Self-reported number of employees

  6-9 months post intervention

Study Arms (2)

Stress and emotion management

EXPERIMENTAL

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.

Behavioral: Stress and emotion management

Control group

NO INTERVENTION

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

Interventions

Stress and emotion management BEHAVIORAL

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.

Also known as: Doing what matters in times of Stress, Acceptance and Commitment Therapy (ACT)

Stress and emotion management

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: identifying as women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• World Bank: lead
• Ethiopian Medical Association: collaborator
• Addis Ababa University: collaborator
• PSI Ethiopia: collaborator

Study Sites (1)

PSI and World Bank, Ethiopia

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Stress, Psychological; Emotional Regulation; Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Naira Kalra, PhD

  World Bank

  PRINCIPAL INVESTIGATOR

• Adiam Hailemicheal, MSc

  World Bank

  PRINCIPAL INVESTIGATOR

• Kassahun Habtamu Mekonnen, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

• Medhin Selamu Tegegn, PhD

  College of health science, Addis Ababa University, Ethiopia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomized using computer generated randomization at one point in time by an independent researcher
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled participants are randomized to intervention or control group

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 26, 2022
• Study Start: July 17, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Post study in 2023. Will be shared for at least 2 years.
• Access Criteria: Publicly available. Use of the dataset must be acknowledged using a citation which would include: * the Identification of the Primary Investigator * the title of the survey (including country, acronym and year of implementation) * the survey reference number * the source and date of download

Locations

ET (1)