Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05208723
Other study ID # DWMTS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04549194 - Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05991739 - Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families N/A
Not yet recruiting NCT05491122 - The Influence of Fluid Intake on Daily Biological Rhythm and Mental Performance in Healthy Young Adults N/A
Completed NCT02982070 - TU Tough: Mental Toughness Training for College Success N/A
Completed NCT02844478 - Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging N/A
Completed NCT02417454 - Study on the Effects of a Probiotic on Autonomic and Psychological Stress Phase 3
Completed NCT06014970 - The Health and Wellness Curriculum Assessment N/A
Completed NCT01946893 - Mindfulness Meditation for Cognition and Mood N/A
Completed NCT01637363 - Psychoeducation to Sick-listed Individuals With Mental Health Problems N/A
Completed NCT01343810 - Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers N/A
Completed NCT00661271 - Mindfulness-based Stress Reduction for Urban Youth N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04125810 - A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress Phase 2
Completed NCT04023968 - Student Wellness Workshop Study N/A
Completed NCT03233750 - Simulation-Based Stress Inoculation Training N/A