NCT06988410

Brief 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. It will advance the scientific knowledge on the effects of economic instability as well as understanding of health gaps across populations.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,267

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 16, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

income instabilityuncertainty

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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

    The measurement will be taken at endline (after 6 2-week periods of intervention).

Study Arms (4)

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.

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.

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.

Behavioral: Work opportunities

Interventions

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.

Predictable Instability ArmStable Income ArmUnpredictable Instability Arm

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between ages of 18 - 60
  • Female
  • Lives in a household with 5 or fewer adults

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Tamale, Ghana

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Heather Schofield, PhD

CONTACT

Leandro Carvalho, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 23, 2025

Study Start

April 17, 2025

Primary Completion

August 29, 2025

Study Completion

October 12, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All de-identified IPD collected throughout the study

Shared Documents
STUDY PROTOCOL, ICF, 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.

Locations