Income Volatility and Mental Health, Pilot Study

Depression Clinical Trial

Official title:

Unstable Income, Rising Stress? The Effect of Income Instability on Psychological and Physiological Health, Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357286
• Other study ID #: IRB0148156
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 10, 2024

Study information

• Verified date: April 2024
• Source: Cornell University
• Contact: Heather Schofield, PhD
• Phone: 6178630726
• Email: hws44[@]cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. Our 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 our understanding of health disparities.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 10, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• between the ages of 18 and 65

• female

• lives in a household with fewer than 5 adults

Exclusion Criteria:

• Pregnancy at enrollment

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Patient Health Questionnaire (PHQ)-8, each item is scored 0-3. Higher scores indicate worse mental health.	Last two weeks