Psychological DistressCARESNCT05971160
Creating Access to Resources and Economic Support
A study testing Financial education videos, Microgrant and Peer mentoring in people with Psychological Distress, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are: 1. Do microgrants with or without peer mentoring improve mental health? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Financial education videos, Microgrant and Peer mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 21 Mar 2026
- 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
- age 18 years or older
- gender identity different from sex assigned on original birth certificate
- access to a mobile phone or email
- score > 0 on the material hardship index
Who cannot join
- inability to provide informed consent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University (online recruitment)
Durham, North Carolina, 27710
About this study
The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are:
- Do microgrants with or without peer mentoring improve mental health?
- Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?
Read more
Researchers will compare mental health outcomes among three groups of participants:
- Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months.
- Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.
- Conditions
- Psychological Distress
- Being tested
- Financial education videos, Microgrant, Peer mentoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial education videosBehavioural
Brief videos providing structured information on managing one's money
MicrograntOther
$150 stipend
Peer mentoringBehavioural
One-on-one structured mentoring sessions with a trained peer
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Monthly financial education videos and one-time microgrant Receives: Behavioral: Financial education videos; Other: Microgrant |
| Monthly microgrants | Active comparator | Monthly financial education videos and monthly microgrants Receives: Behavioral: Financial education videos; Other: Microgrant |
| Monthly microgrants plus peer mentoring | Active comparator | Monthly financial education videos, monthly microgrants, and peer mentoring support Receives: Behavioral: Financial education videos; Other: Microgrant; Behavioral: Peer mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological distress, as measured by Kessler 6
Kessler 6 is a 6-item scale with each item scored from 0-4 for a total score range from 0-24, with higher scores indicating greater psychological distress.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
DAST-10 is a 10-item scale with with one one point for each "yes" response for a total score range from 0-10, with higher scores indicating more problematic substance use
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Dec 2023
- Primary completion21 Mar 2026
- Study completion21 Mar 2026
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 Psychological DistressStudies of the same condition, open and under way.
- More trials run by Duke 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Tonia C. Poteat, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971160
- Sponsor's protocol ID
- Pro00113319
- Other IDs
- R01MD016755
- Acronym
- CARES
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share data via one of the NIH repositories listed by the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC). The final available dataset from this proposed research will include self-reported demographic, psychosocial, and behavioral data from quantitative surveys. No personal identifiers will be included with the final available dataset.
Publications
Poteat TC, Reisner SL, Wirtz AL, Mayo-Wilson LJ, Brown C, Kornbluh W, Humphrey A, Perrin N. A Microfinance Intervention With or Without Peer Support to Improve Mental Health Among Transgender and Nonbinary Adults (the Creating Access to Resources and Economic Support Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 26;13:e63656. doi: 10.2196/63656.
PubMed 39186770
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Access to Resources and Economic Support
- ClinicalTrials.gov ID
- NCT05971160
- Acronym / sponsor ID
- CARES / Pro00113319
- Conditions
- Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- 21 Mar 2026 (actual)
- First posted
- 2 Aug 2023 (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.
The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are:
- Do microgrants with or without peer mentoring improve mental health?
- Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?
Researchers will compare mental health outcomes among three groups of participants:
- Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months.
- Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Financial education videos, Other: MicrograntMonthly financial education videos and one-time microgrant |
| Monthly microgrants | Active comparator | Behavioral: Financial education videos, Other: MicrograntMonthly financial education videos and monthly microgrants |
| Monthly microgrants plus peer mentoring | Active comparator | Behavioral: Financial education videos, Other: Microgrant, Behavioral: Peer mentoringMonthly financial education videos, monthly microgrants, and peer mentoring support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- gender identity different from sex assigned on original birth certificate
- access to a mobile phone or email
- score > 0 on the material hardship index
Key exclusion criteria (1 listed)
- inability to provide informed consent in English
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 |
|---|---|---|
| Financial education videosBrief videos providing structured information on managing one's money | Behavioural | Monthly microgrants, Monthly microgrants plus peer mentoring, Usual Care |
| Microgrant$150 stipend | Other | Monthly microgrants, Monthly microgrants plus peer mentoring, Usual Care |
| Peer mentoringOne-on-one structured mentoring sessions with a trained peer | Behavioural | Monthly microgrants plus peer mentoring |
Primary outcome
Change in psychological distress, as measured by Kessler 6
Time frame: Baseline, 6 months, 12 months
Kessler 6 is a 6-item scale with each item scored from 0-4 for a total score range from 0-24, with higher scores indicating greater psychological distress.
1 secondary outcome
Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
Time frame: Baseline, 6 months, 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 27 Mar 2026.
- Derived from this study: PubMed 39186770Poteat TC, Reisner SL, Wirtz AL, Mayo-Wilson LJ, Brown C, Kornbluh W, Humphrey A, Perrin N. A Microfinance Intervention With or Without Peer Support to Improve Mental Health Among Transgender and Nonbinary Adults (the Creating Access to Resources and Economic Support Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 26;13:e63656. doi: 10.2196/63656.
- Individual participant dataSharing planned: Yes. The investigators plan to share data via one of the NIH repositories listed by the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC). The final available dataset from this proposed research will include self-reported demographic, psychosocial, and behavioral data from quantitative surveys. No personal identifiers will be included with the final available dataset.
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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.
Tonia C. Poteat, PhD principal investigator
Duke 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 Financial education videos, Microgrant and Peer mentoring in people with Psychological Distress, run by Duke 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 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 27 Mar 2026. 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?
Change in psychological distress, as measured by Kessler 6 (time frame: Baseline, 6 months, 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 NCT05971160, 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 27 Mar 2026.