DepressionNCT06988410
Income Volatility and Mental Health, Full Experiment
A study testing Work opportunities in people with Depression and Anxiety, run by Cornell University at 1 site in Ghana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Blood Pressure
- What is being tested?
- Work opportunities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,267 participants
- Where
- 1 siteGhana
- Study dates
- 17 Apr 2025to 12 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between ages of 18 - 60
- Female
- Lives in a household with 5 or fewer adults
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leandro Carvalho, PhD contact
Ghana1 site, 1 recruiting
- Recruiting
Innovations for Poverty Action
Tamale
Salifu Amadu, 0000000000, samadu@poverty-action.org
About this study
Official title: Unstable Income, Rising Stress? The Effect of Income Instability on Psychological and Physiological Health
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.
Read the detailed description
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.
- Conditions
- Depression, Anxiety, Blood Pressure
- Being tested
- Work opportunities
- Keywords
- income instability, uncertainty
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work opportunitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The Control arm will not be hired by the cash-for-work program but will be surveyed. |
| Stable Income Arm | Experimental | The Stable Income arm will work the same amount and earn the same amount every period. Receives: Behavioral: Work opportunities |
| Predictable Instability Arm | Experimental | 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. Receives: Behavioral: Work opportunities |
| Unpredictable Instability Arm | Experimental | 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. Receives: Behavioral: Work opportunities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: The measurement will be taken at endline (after 6 2-week periods of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start17 Apr 2025
- Primary completion29 Aug 2025 (estimated)
- Study completion12 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Innovations for Poverty Action
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988410
- Sponsor's protocol ID
- OSP169128
- Other IDs
- R01AG076655
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD collected throughout the study
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unstable Income, Rising Stress? The Effect of Income Instability on Psychological and Physiological Health
- ClinicalTrials.gov ID
- NCT06988410
- Acronym / sponsor ID
- OSP169128
- Conditions
- Depression, Anxiety, Blood Pressure
- Keywords
- income instability, uncertainty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,267 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Innovations for Poverty Action
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 12 Oct 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The Control arm will not be hired by the cash-for-work program but will be surveyed. |
| Stable Income Arm | Experimental | Behavioral: Work opportunitiesThe Stable Income arm will work the same amount and earn the same amount every period. |
| Predictable Instability Arm | Experimental | Behavioral: Work opportunitiesThe 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. |
| Unpredictable Instability Arm | Experimental | Behavioral: Work opportunitiesThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between ages of 18 - 60
- Female
- Lives in a household with 5 or fewer adults
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Work opportunitiesIndividuals 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. | Behavioural | Predictable Instability Arm, Stable Income Arm, Unpredictable Instability Arm |
Primary outcome
Depression
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.
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.
Anxiety
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.
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.
Dietary Diversity
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.
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).
Blood Pressure
Time frame: The measurement will be taken at endline (after 6 2-week periods of intervention).
Blood Pressure Measurement, recorded in millimeters of mercury (mmHg) with two components: systolic and diastolic. Higher values indicate increased cardiovascular risk
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes. All de-identified IPD collected throughout the study
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leandro Carvalho, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Work opportunities in people with Depression and Anxiety, run by Cornell University at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Schofield, PhD (6178630726, hws44@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.