An interventional study of Work opportunities in Depression, Anxiety and Blood Pressure, sponsored by Cornell University. Recruiting at 1 site in Ghana. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Cornell University · Not applicable, Interventional, and Other
Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. This research is the first to assess the causal effects of predictable and unpredictable income instability on the psychological and physical health of the poor. It will advance the scientific knowledge on the effects of economic instability as well as understanding of health gaps across populations.
The poor suffer disproportionally from poor mental and physical health. Many causes for these differences have been considered, including low income. But, poor families' incomes are not only low, but also often unstable and unpredictable. This instability creates uncertainty about whether individuals will be able to safeguard their future well-being. According to the allostatic load framework, prolonged activation of physiological stress responses will cause "wear and tear" on the body, heightening risks of cardiovascular disease and of age-related metabolic diseases, promoting cognitive decline and dementia, and accelerating cellular aging.
This research will study the causal effects of income instability on the psychological and physical health of the poor. The study's specific aims are to: 1) Identify the causal effect of income instability on psychological health (e.g. depression, anxiety), and physical health (e.g. blood pressure), 2) Decompose the effects identified in aim 1 into the effects of predictable and unpredictable instability and compare to the impact of increasing the average level of income, and 3) Investigate the channels through which effects on health occur, including both economic and behavioral channels and estimate the impact of key moderating factors (e.g. age, baseline mental health).
The trial will be conducted in northern Ghana. It will manipulate income instability by varying the number of work hours (and hence earnings) of participants in a cash-for-work program. Participants in the first treatment arm will have a fixed work schedule, with the same hours and earning each period. The hours and earnings of a second treatment arm will vary over time, but the fluctuations will be known in advance. Finally, the number of work hours and earnings of a third treatment arm will fluctuate unpredictably. Each of these arms will be compared to a control group that is surveyed, but not offered additional work. Importantly, the study will vary income instability while holding the average level of income constant in order to disentangle the impact of instability from the level-effect.
The study will create 1,867 new jobs that would not otherwise be available during the lean season when jobs are scarce. The intervention has been designed so that the job opportunity cannot make the participants worse off than they would otherwise have been in the absence of research.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 2,267 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The Control arm will not be hired by the cash-for-work program but will be surveyed.
The Stable Income arm will work the same amount and earn the same amount every period.
Behavioral: Work opportunities
The hours and earnings of the Predictable Instability arm will vary over time. In three periods, the participant will work longer hours and will earn more. In the remaining three periods, she will work fewer hours and will earn less. However, on average, the work offered will be the same as in the stable arm. Crucially, she will be able to predict all swings in her study earnings in the future-i.e., she will know her hours and earnings in each future period.
Behavioral: Work opportunities
The hours and earnings of the Unpredictable Instability arm will vary unpredictably over time. In any given period, there will be a 50% chance that she works longer hours and earns more and a 50% chance that she works fewer hours and earns less. The expected average earnings remain the same as the stable arm and the predictable arm, though specific individuals may earn more or less.
Behavioral: Work opportunities
Individuals in the treated arms of the study will be offered work opportunities (sewing bags) to earn cash. The timing of these opportunities and knowledge of the amount and timing varies by experimental arm.
Depression
Patient Health Questionnaire (PHQ)-8, each item is scored 0-3. Multiplying the range per item (0-3) by the number of items (8) gives the total corresponding range of the scale: 0 to 24. Higher scores indicate worse mental health.
Time frame: The measurement will be taken at endline (after 6 2-week periods of intervention). Respondents will be asked to evaluate each item over the last 10 days.
Anxiety
Generalized Anxiety Disorder (GAD)-7 scale, each item is scored 0-3. Multiplying the range per item (0-3) by the number of items (7) gives the total corresponding range of the scale: 0 to 21. Higher scores indicate worse mental health.
Time frame: The measurement will be taken at endline (after 6 2-week periods of intervention). Respondents will be asked to evaluate each item over the last 10 days.
Dietary Diversity
The Household Dietary Diversity Score is used to measure households' food access on the number of food groups they had consumed (out of 11). The measure sums the number of categories with any positive consumption by the household resulting in a total score between 0 and 11. Households that consume a greater number of food groups are considered to have greater dietary diversity (i.e. more is better).
Time frame: The measurement will be taken at endline (after 6 2-week periods of intervention). Respondents will be asked to evaluate each item over the last ten days.
Blood Pressure
Blood Pressure Measurement, recorded in millimeters of mercury (mmHg) with two components: systolic and diastolic. Higher values indicate increased cardiovascular risk
Time frame: The measurement will be taken at endline (after 6 2-week periods of intervention).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All de-identified IPD collected throughout the study
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Within 1 year after publication with no end date
Access criteria: No criteria, any individual who would like to download it from the PI's website or a public repository.
Started Apr 2025 (actual). Primary completion is estimated for Aug 2025, 4 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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