Economic Problems, Emotion Regulation, Mental Stress, Social Psychology, Stress, Psychological
Conditions
Keywords
Stress management, Economic benefits, Mental health
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.
Detailed 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.
Interventions
BEHAVIORALStress 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.
Sponsors
Ethiopian Medical Association
Addis Ababa University
PSI Ethiopia
World Bank
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Randomized using computer generated randomization at one point in time by an independent researcher
Intervention model description
Enrolled participants are randomized to intervention or control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental Distress using the Kessler Psychological Distress Scale (K-6) | 4-6 weeks post intervention | Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome) |
| Depression using the Patient Health Questionnaire (PHQ-9) | 4-6 weeks post intervention | Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome). |
| Stress using the Perceived Stress Scale | 4-6 weeks post intervention | 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 |
| Self-reported Business outcomes | 6-9 months post intervention | Self-reported past month profits in local currency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Esteem using the Rosenberg Self-esteem Scale | 4-6 weeks post intervention | 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) |
| Self-reported number of employees | 6-9 months post intervention | Average self-reported number of employees |
| Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version) | 6-9 months post intervention | Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome) |
| World Health Organisation- Five Well-Being Index (WHO-5) | 4-6 weeks post intervention | 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. |
| Self-reported Business Closure | 4-6 weeks post intervention | Self-reported business closure |
| Self-reported number of recent hires | 4-6 weeks post intervention | Average self-reported number of employees hired in the past month |
| Self-reported Business outcomes | 4-6 weeks post intervention | Self-reported past month profits in local currency |
Countries
Ethiopia
Outcome results
None listed