DepressionEARN-HealthNCT02185612
The EARN-Health Trial of Financial Savings and Health
A study testing Savings program in people with Depression and Anxiety, run by Stanford University at 1 site in United States.
Trial summary
The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Alcohol Abuse
- What is being tested?
- Savings program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 13 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking US residents
- ages 18 and older
- below 50% of the area median income
- have a regular Internet connection
Who cannot join
- non-English speakers
- non-US residents
- children,
- history of or current enrollment in other incentivized savings programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EARN-Health: A Randomized Controlled Trial of the Effects of an Incentivized Savings Program on Depression, Anxiety, Substance Abuse, and Locus of Control
The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of "goal-based savings accounts" or "matched savings accounts" in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety.
(2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature.
(3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.
Read the detailed description
The investigators plan to conduct an RCT comparing participants in the new EARN program against wait-listed control subjects. The program provides low-wage workers with incentives and rewards for savings. The program involves a web-based platform that permits eligible savers to create a centralized savings account, which is a secure online account without fees. The account offers eligible savers small monetary rewards for dollars saved each month. The investigators plan to conduct a baseline online month 0 survey and a follow-up 6 month and 12 month online survey among participants and wait-listed nonparticipants, with telephone follow-up to maximize 6- and 12-month survey completion. The surveys consist of previously-validated instruments to assess key health behaviors self-reported well-being, and require approximately 20 minutes each. The surveys includes the CDC Behavioral Risk Factor Surveillance System scales for assessing demographics and income, overall self-rated health, tobacco and alcohol use, depression and anxiety symptoms, and optimism and locus of control. Participants will receive prorated a gift card for each survey, to compensate participants for their time while avoiding a direct income effect of a cash incentive for participation.
- Conditions
- Depression, Anxiety, Alcohol Abuse, Tobacco Abuse
- Being tested
- Savings program
- Medical subject headings
- Depression, Anxiety Disorders, Alcoholism, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savings programBehavioural
The intervention is a web-based centralized savings account, which is a secure online account without fees. The account offers eligible savers nominal financial rewards for each deposit they make, as a financial incentive for savings.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will be randomized to a 1 year wait list. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health. |
| Savings program | Experimental | Participants will be randomized to the EARN.org online savings program for 6 months. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health. Receives: Behavioral: Savings program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rated health scales
The following survey measures of self-rated health are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:
H0) Would you say that in general your health, as compared to other people your age, is…?
[ Excellent Very good Good Fair OR Poor ]
H1) Please think about your physical health. This includes physical illness and injury. How many days during the past 30 days was your physical health not good?
[Number from 0 to 30]
H2) Now please think about your emotional health. This includes stress, depression, and anxiety. How many days during the past 30 days was your emotional health not good?
[Number from 0 to 30]
H3) During the past 30 days, for about how many days did poor physical or emotional health keep you from doing your usual activities, such as self-care, work, or recreation?
[Number from 0 to 30]
Measured: 12 months
Secondary outcomes (6)
Depression and anxiety symptoms: yes/no questions
The following survey measures are taken from the validated Patient Health Questionnaire 8 and will be recorded and reported from our study:
M1) Little interest or pleasure in doing things M2) Feeling down, depressed, or hopeless M3) Trouble falling asleep or staying asleep, or sleeping too much M4) Feeling tired or having little energy M5) Poor appetite or overeating M6) Feeling bad about yourself, or that you are a failure, or have let yourself or your family down M7) Trouble concentrating on things, such as reading the newspaper or watching television M8) Moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.
Measured: 12 months
Alcohol abuse screening questions
The following survey measures of alcohol use are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:
A1) During the past 30 days, how many days did you have at least one drink of any alcoholic beverage? This includes beer, wine, malt beverages, and liquor.
Days in past 30 days
A2) A drink of alcohol is 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 cocktail, or 1 shot of liquor. During the past 30 days, how many days per week or per month did you have at least one drink of any alcoholic beverage?
A3) Considering all types of alcoholic beverages, how many times during the past 30 days did you have X [Script: X = 5 for men, X = 4 for women] or more drinks on an occasion?
Measured: 12 months
Tobacco abuse screening questions
The following survey measures of tobacco use are taken from the validated CDC's Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:
T0) Have you smoked at least 100 cigarettes in your entire life? yes no Script: If NO go to Part 5, else go to "T1"
T1) Do you now smoke cigarettes every day, some days, or not at all? every day some days not at all
T2) During the past 6 months, have you stopped smoking for one day or longer because you were trying to quit smoking?
Measured: 12 months
Locus of control Likert scales
The following survey measures are taken from the validated Health and Retirement study to assess locus of control, and will be recorded and reported from our study::
Please read the statements below and indicate the extent to which you agree with each statement. Select one of the following: Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree O1) In uncertain times, I expect the best O2) If something can go wrong for me, it will O3) I'm always optimistic about the future O4) I hardly ever expect things to go my way O5) I rarely count on good things happening to me O6) Overall, I expect more good things to happen to me than bad
Measured: 12 months
Optimism Likert scales
The following survey measures are taken from the validated Health and Retirement study to assess optimism, and will be recorded and reported from our study::
L1) I have little control over the things that happen to me L2) There is really no way I can solve some of the problems I have L3) There is little I can do to change many of the important things in my life L4) I often feel helpless in dealing with the problems of life L5) Sometimes I feel that I'm being pushed around in life L6) What happens to me in the future mostly depends on me L7) I can do just about anything I really set my mind to do
Measured: 12 months
Spending behaviors
The following survey measures of spending behaviors will be recorded and reported from our study:
S1) Over the past six months, would you say your household has been... Spending less money than you have had coming in. Spending more money than you have had coming in. Spending about the same amount of money that you have had coming in. S2) Over the past six months, which most accurately describes your household? We put aside money as savings every paycheck or every month. We put aside money as savings when we can, but not regularly. We didn't really put aside money as savings. S3) How much money did your household put aside as savings in an average month? We did not put aside savings in an average month. S4) Does your household have a monthly spending plan? Yes, and we mostly stick to it. Yes, but we don't really stick to it. No, we do not have a plan.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 2016
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Basu, MD. PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185612
- Sponsor's protocol ID
- 30641
- Acronym
- EARN-Health
- Status last verified
- Sep 2021
- First submitted
- 2 Jul 2014
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Basu S, Hamad R, White JS, Modrek S, Rehkopf DH, Cullen MR. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults. BMJ Open. 2015 Oct 6;5(10):e009366. doi: 10.1136/bmjopen-2015-009366.
PubMed 26443663
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARN-Health: A Randomized Controlled Trial of the Effects of an Incentivized Savings Program on Depression, Anxiety, Substance Abuse, and Locus of Control
- ClinicalTrials.gov ID
- NCT02185612
- Acronym / sponsor ID
- EARN-Health / 30641
- Conditions
- Depression, Anxiety, Alcohol Abuse, Tobacco Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 9 Jul 2014 (estimated)
- 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.
The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of "goal-based savings accounts" or "matched savings accounts" in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety.
(2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature.
(3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.
Detailed description
The investigators plan to conduct an RCT comparing participants in the new EARN program against wait-listed control subjects. The program provides low-wage workers with incentives and rewards for savings. The program involves a web-based platform that permits eligible savers to create a centralized savings account, which is a secure online account without fees. The account offers eligible savers small monetary rewards for dollars saved each month. The investigators plan to conduct a baseline online month 0 survey and a follow-up 6 month and 12 month online survey among participants and wait-listed nonparticipants, with telephone follow-up to maximize 6- and 12-month survey completion. The surveys consist of previously-validated instruments to assess key health behaviors self-reported well-being, and require approximately 20 minutes each. The surveys includes the CDC Behavioral Risk Factor Surveillance System scales for assessing demographics and income, overall self-rated health, tobacco and alcohol use, depression and anxiety symptoms, and optimism and locus of control. Participants will receive prorated a gift card for each survey, to compensate participants for their time while avoiding a direct income effect of a cash incentive for participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will be randomized to a 1 year wait list. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health. |
| Savings program | Experimental | Behavioral: Savings programParticipants will be randomized to the EARN.org online savings program for 6 months. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking US residents
- ages 18 and older
- below 50% of the area median income
- have a regular Internet connection
Key exclusion criteria (4 listed)
- non-English speakers
- non-US residents
- children,
- history of or current enrollment in other incentivized savings programs
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 |
|---|---|---|
| Savings programThe intervention is a web-based centralized savings account, which is a secure online account without fees. The account offers eligible savers nominal financial rewards for each deposit they make, as a financial incentive for savings. | Behavioural | Savings program |
Primary outcome
Self-rated health scales
Time frame: 12 months
The following survey measures of self-rated health are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study: H0) Would you say that in general your health, as compared to other people your age, is…? [ Excellent Very good Good Fair OR Poor ] H1) Please think about your physical health. This includes physical illness and injury. How many days during the past 30 days was your physical health not good? [Number from 0 to 30] H2) Now please think about your emotional health. This includes stress, depression, and anxiety. How many days during the past 30 days was your emotional health not good? [Number from 0 to 30] H3) During the past 30 days, for about how many days did poor physical or emotional health keep you from doing your usual activities, such as self-care, work, or recreation? [Number from 0 to 30]
6 secondary outcomes
Depression and anxiety symptoms: yes/no questions
Time frame: 12 months
Alcohol abuse screening questions
Time frame: 12 months
Tobacco abuse screening questions
Time frame: 12 months
Locus of control Likert scales
Time frame: 12 months
Optimism Likert scales
Time frame: 12 months
Spending behaviors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 26443663Basu S, Hamad R, White JS, Modrek S, Rehkopf DH, Cullen MR. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults. BMJ Open. 2015 Oct 6;5(10):e009366. doi: 10.1136/bmjopen-2015-009366.
- Individual participant dataSharing planned: No
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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.
Sanjay Basu, MD. PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savings program in people with Depression and Anxiety, run by Stanford University at 1 site in United States.
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 4 inclusion and 4 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 28 Sep 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-rated health scales (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185612, which also lists 1 linked publication.
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 28 Sep 2021.