An interventional study of Stress and emotion management in Stress, Psychological, Emotion Regulation and Social Psychology, sponsored by World Bank. Status unknown at 1 site in Ethiopia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by World Bank · Not applicable, Interventional, and Prevention
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.
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.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 200 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.
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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
No intervention. May receive intervention post study if findings are indicative of any benefit.
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)
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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 6-9 months post intervention
Self-reported Business outcomes
Self-reported past month profits in local currency
Time frame: 6-9 months post intervention
Self-reported Business outcomes
Self-reported past month profits in local currency
Time frame: 4-6 weeks post intervention
Self-reported Business Closure
Self-reported business closure
Time frame: 4-6 weeks post intervention
Self-reported Business Closure
Self-reported business closure
Time frame: 6-9 months post intervention
Self-reported number of recent hires
Average self-reported number of employees hired in the past month
Time frame: 4-6 weeks post intervention
Self-reported number of employees
Average self-reported number of employees
Time frame: 6-9 months post intervention
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)
Time frame: 4-6 weeks post intervention
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)
Time frame: 6-9 months post intervention
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.
Time frame: 4-6 weeks post intervention
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.
Time frame: 6-9 months post intervention
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)
Time frame: 6-9 months post intervention
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)
Time frame: 4-6 weeks post intervention
Plan to share: Yes — All unidentified IPD that underlie results in a publication will be shared if doing so is approved by the Institutional Review Board and clears privacy and security requirements set by the World Bank microdata portal.
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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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