DepressionNCT06357286
Income Volatility and Mental Health, Pilot Study
A study testing Work opportunities in people with Depression, 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. 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- 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
- 390 participants
- Where
- 1 siteGhana
- Study dates
- 25 May 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 65
- female
- lives in a household with fewer than 5 adults
Who cannot join
- Pregnancy at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unstable Income, Rising Stress? The Effect of Income Instability on Psychological and Physiological Health, Pilot Study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Work opportunities
- Medical subject headings
- Depression
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 number of hours (36) and earn the same amount (108 cedis) 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 (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. 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 (60) and earns more (180 cedis) and a 50% chance that she works fewer hours (12) and earns less (36 cedis). 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 was taken at endline (after 8 weeks of intervention). Respondents were asked to evaluate each item over the last two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start25 May 2024
- Primary completion10 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357286
- Sponsor's protocol ID
- IRB0148156
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2024
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified survey data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 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, Pilot Study
- ClinicalTrials.gov ID
- NCT06357286
- Acronym / sponsor ID
- IRB0148156
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Posted 15 Apr 2025
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. 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.
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 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 number of hours (36) and earn the same amount (108 cedis) 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 (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. |
| 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 (60) and earns more (180 cedis) and a 50% chance that she works fewer hours (12) and earns less (36 cedis). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between the ages of 18 and 65
- female
- lives in a household with fewer than 5 adults
Key exclusion criteria (1 listed)
- Pregnancy at enrollment
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 was taken at endline (after 8 weeks of intervention). Respondents were asked to evaluate each item over the last two weeks.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. De-identified survey data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, 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: finished, as of the sponsor's last update on 15 Apr 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?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: The measurement was taken at endline (after 8 weeks of intervention). Respondents were asked to evaluate each item over the last two weeks.). 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 15 Apr 2025.