- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06357286
Income Volatility and Mental Health, Pilot Study
Unstable Income, Rising Stress? The Effect of Income Instability on Psychological and Physiological Health, Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The poor suffer disproportionally from poor mental and physical health. Many causes for these disparities 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 they will be able to safeguard their future wellbeing. 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. Our specific aims are to: 1) Identify the causal effect of income instability on psychological health (e.g. depression, anxiety), biomarkers of stress (e.g. cortisol), 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, gender, baseline mental health).
The trial will be conducted in northern Ghana. We 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, we 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 full 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 them worse off than they would otherwise have been in the absence of research.
Please note this registration is for a pilot study (n= approximately 400) prior to the main experiment. As such, we anticipate the pilot will be underpowered and do not expect to find significant effects.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather Schofield, PhD
- Phone Number: 6178630726
- Email: hws44@cornell.edu
Study Contact Backup
- Name: Leandro Carvalho, PhD
- Email: lcarvalh@usc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between the ages of 18 and 65
- female
- lives in a household with fewer than 5 adults
Exclusion Criteria:
- Pregnancy at enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
|
Experimental: Stable income arm
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
|
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.
|
Experimental: Predictable Instability Arm
The hours and earnings of the Predictable Instability arm will vary over time.
In three periods, the participant will work longer hours (60) and will earn more (180 cedis).
In the remaining three periods, she will work fewer hours (12) and will earn less (36 cedis).
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.
|
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.
|
Experimental: Unpredictable Instability Arm
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 (60) and earns more (180 cedis) and a 50% chance that she works fewer hours (12) and earns less (36 cedis).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Last two weeks
|
Patient Health Questionnaire (PHQ)-8, each item is scored 0-3.
Higher scores indicate worse mental health.
|
Last two weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0148156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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