Trial Outcomes & Findings for Income Volatility and Mental Health, Pilot Study (NCT NCT06357286)
NCT ID: NCT06357286
Last Updated: 2025-04-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
390 participants
Primary outcome timeframe
The measurement was taken at endline (after 8 weeks of intervention). Respondents were asked to evaluate each item over the last two weeks.
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Control
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
Stable Income Arm
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
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.
|
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.
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.
|
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).
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
80
|
83
|
157
|
|
Overall Study
COMPLETED
|
67
|
80
|
82
|
155
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Income Volatility and Mental Health, Pilot Study
Baseline characteristics by cohort
| Measure |
Control
n=70 Participants
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
Stable Income Arm
n=80 Participants
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
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.
|
Predictable Instability Arm
n=83 Participants
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.
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.
|
Unpredictable Instability Arm
n=157 Participants
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).
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.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
390 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
37.5 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
390 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
390 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Ghana
|
70 participants
n=5 Participants
|
80 participants
n=7 Participants
|
83 participants
n=5 Participants
|
157 participants
n=4 Participants
|
390 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=67 Participants
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
Stable Income Arm
n=80 Participants
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
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.
|
Predictable Instability Arm
n=82 Participants
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.
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.
|
Unpredictable Instability Arm
n=155 Participants
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).
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.
|
|---|---|---|---|---|
|
Depression
|
7.4 units on a scale
Standard Deviation 4.4
|
5.7 units on a scale
Standard Deviation 4.1
|
6.3 units on a scale
Standard Deviation 4.0
|
7.4 units on a scale
Standard Deviation 4.8
|
Adverse Events
Control
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Stable Income Arm
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Predictable Instability Arm
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Unpredictable Instability Arm
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=70 participants at risk
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
Stable Income Arm
n=80 participants at risk
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
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.
|
Predictable Instability Arm
n=83 participants at risk
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.
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.
|
Unpredictable Instability Arm
n=157 participants at risk
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).
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.
|
|---|---|---|---|---|
|
General disorders
hospitalized for fever
|
1.4%
1/70 • Number of events 1 • 4 months
Follow standard definitions
|
0.00%
0/80 • 4 months
Follow standard definitions
|
0.00%
0/83 • 4 months
Follow standard definitions
|
0.64%
1/157 • Number of events 1 • 4 months
Follow standard definitions
|
|
Musculoskeletal and connective tissue disorders
pain
|
1.4%
1/70 • Number of events 1 • 4 months
Follow standard definitions
|
0.00%
0/80 • 4 months
Follow standard definitions
|
0.00%
0/83 • 4 months
Follow standard definitions
|
0.00%
0/157 • 4 months
Follow standard definitions
|
|
Gastrointestinal disorders
pain
|
0.00%
0/70 • 4 months
Follow standard definitions
|
0.00%
0/80 • 4 months
Follow standard definitions
|
0.00%
0/83 • 4 months
Follow standard definitions
|
0.64%
1/157 • Number of events 1 • 4 months
Follow standard definitions
|
Other adverse events
| Measure |
Control
n=70 participants at risk
The Control arm will not be hired by the cash-for-work program but will be surveyed.
|
Stable Income Arm
n=80 participants at risk
The Stable Income arm will work the same number of hours (36) and earn the same amount (108 cedis) every period.
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.
|
Predictable Instability Arm
n=83 participants at risk
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.
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.
|
Unpredictable Instability Arm
n=157 participants at risk
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).
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.
|
|---|---|---|---|---|
|
General disorders
accidents and injuries
|
1.4%
1/70 • Number of events 1 • 4 months
Follow standard definitions
|
0.00%
0/80 • 4 months
Follow standard definitions
|
2.4%
2/83 • Number of events 2 • 4 months
Follow standard definitions
|
2.5%
4/157 • Number of events 4 • 4 months
Follow standard definitions
|
|
General disorders
pain
|
8.6%
6/70 • Number of events 7 • 4 months
Follow standard definitions
|
1.2%
1/80 • Number of events 1 • 4 months
Follow standard definitions
|
4.8%
4/83 • Number of events 4 • 4 months
Follow standard definitions
|
8.3%
13/157 • Number of events 13 • 4 months
Follow standard definitions
|
|
General disorders
fatigue and/or dizziness
|
0.00%
0/70 • 4 months
Follow standard definitions
|
2.5%
2/80 • Number of events 2 • 4 months
Follow standard definitions
|
1.2%
1/83 • Number of events 1 • 4 months
Follow standard definitions
|
1.3%
2/157 • Number of events 2 • 4 months
Follow standard definitions
|
|
Gastrointestinal disorders
gastrointestinal distress
|
0.00%
0/70 • 4 months
Follow standard definitions
|
5.0%
4/80 • Number of events 4 • 4 months
Follow standard definitions
|
3.6%
3/83 • Number of events 3 • 4 months
Follow standard definitions
|
3.2%
5/157 • Number of events 5 • 4 months
Follow standard definitions
|
|
General disorders
headache
|
2.9%
2/70 • Number of events 2 • 4 months
Follow standard definitions
|
6.2%
5/80 • Number of events 5 • 4 months
Follow standard definitions
|
6.0%
5/83 • Number of events 6 • 4 months
Follow standard definitions
|
5.1%
8/157 • Number of events 8 • 4 months
Follow standard definitions
|
|
Infections and infestations
infectious diseases
|
4.3%
3/70 • Number of events 3 • 4 months
Follow standard definitions
|
8.8%
7/80 • Number of events 7 • 4 months
Follow standard definitions
|
15.7%
13/83 • Number of events 14 • 4 months
Follow standard definitions
|
12.7%
20/157 • Number of events 23 • 4 months
Follow standard definitions
|
|
General disorders
rash or swelling
|
1.4%
1/70 • Number of events 1 • 4 months
Follow standard definitions
|
1.2%
1/80 • Number of events 1 • 4 months
Follow standard definitions
|
0.00%
0/83 • 4 months
Follow standard definitions
|
0.00%
0/157 • 4 months
Follow standard definitions
|
|
General disorders
spiritual illness
|
0.00%
0/70 • 4 months
Follow standard definitions
|
1.2%
1/80 • Number of events 1 • 4 months
Follow standard definitions
|
1.2%
1/83 • Number of events 1 • 4 months
Follow standard definitions
|
0.00%
0/157 • 4 months
Follow standard definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place