Well-beingNCT06652711
Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention
A study testing 2-month access to mental health app, Direct incentive and 4-month access to mental health app in people with Well-being and Mental Health, run by University of Texas at Austin at 1 site in United States.
Trial summary
We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Well-being, Mental Health
- What is being tested?
- 2-month access to mental health app, Direct incentive and 4-month access to mental health app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
The target population will be: immigrants to the U.S. of Hispanic origin whose native language is Spanish, who have been living in the U.S. (intermittently or continuously) for less than 10 years, who are over 18 years of age, who have a PHQ4 score that is three or more, who would be interested in using a well-being phone app, who do not have a graduate degree and have access to a smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Raissa Fabregas, 512-471-7349, rfabregas@utexas.edu
About this study
We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.
- Conditions
- Well-being, Mental Health
- Being tested
- 2-month access to mental health app, Direct incentive, 4-month access to mental health app, Lottery incentive
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-month access to mental health appBehavioural
Participants will have access to the well-being app for two months.
Direct incentiveBehavioural
A $10 gift card are given to participants at the end of the study if they used the app sufficiently.
4-month access to mental health appBehavioural
Participants will have access to the well-being app for four months.
Lottery incentiveBehavioural
Participants can participate in a draw of $150 gift cards at the end of the study if they used the app sufficiently.
| Study group | Role | What they receive |
|---|---|---|
| 2-month access and no incentive | Experimental | Participants have access to the well-being app for two months and receive no incentive for using the app. Receives: Behavioral: 2-month access to mental health app |
| 2-month access and lottery incentive | Experimental | Participants have access to the well-being app for two months, and participate in a lottery for gift cards if they display sufficient engagement. Receives: Behavioral: 2-month access to mental health app; Behavioral: Lottery incentive |
| 2-month access and direct incentive | Experimental | Participants have access to the well-being app for two months, and receive a direct payment if they display sufficient engagement. Receives: Behavioral: 2-month access to mental health app; Behavioral: Direct incentive |
| 4-month access and no incentive | Experimental | Participants have access to the well-being app for four months and receive no incentive for using the app. Receives: Behavioral: 4-month access to mental health app |
| 4-month access and lottery incentive | Experimental | Participants have access to the well-being app for four months, and participate in a lottery for gift cards if they display sufficient engagement. Receives: Behavioral: 4-month access to mental health app; Behavioral: Lottery incentive |
| 4-month access and direct incentive | Experimental | Participants have access to the well-being app for four months, and receive a direct payment if they display sufficient engagement. Receives: Behavioral: Direct incentive; Behavioral: 4-month access to mental health app |
| control | No intervention | Participants do not have access to the app during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, anxiety, and stress
Measured by the Patient Health Questionnaire 8 (PHQ)
Measured: Up to six months since enrollment
Anxiety
Measured by GAD-7 (General Anxiety Disorder Questionnaire)
Measured: Up to six months since enrollment
Stress
Measured by PSS-4 (Perceived Stress Scale 4)
Measured: Up to six months since enrollment
Self-efficacy
Measured using the short version of the General Self-Efficacy Scale, the GSE-6
Measured: Up to six months since enrollment
Locus of Control
Measure using the Internal-External Locus of Control Short Scale-4 (IE-4)
Measured: Up to six months since enrollment
Secondary outcomes (2)
Remittances
Amount and frequency of remittances to the participants' countries of origin
Measured: Up to six months since enrollment
Social connectedness and Integration to the US
we will measure this with a subset of questions of the Multidimensional Measure of Immigrant Integration (Harder et al. 2018), with questions about: psychological integration, linguistic integration, political and economic integration and social integration. We will report these separately and combining them through an Anderson index (Anderson, 2008). In addition, as a second outcome we will use a revealed-choice measures of their demand to invest in learning English (by giving them a choice between access to a language course or cash/item)
Measured: Up to six months since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Sep 2024
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652711
- Sponsor's protocol ID
- STUDY00005337
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention
- ClinicalTrials.gov ID
- NCT06652711
- Acronym / sponsor ID
- STUDY00005337
- Conditions
- Well-being, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 2-month access and no incentive | Experimental | Behavioral: 2-month access to mental health appParticipants have access to the well-being app for two months and receive no incentive for using the app. |
| 2-month access and lottery incentive | Experimental | Behavioral: 2-month access to mental health app, Behavioral: Lottery incentiveParticipants have access to the well-being app for two months, and participate in a lottery for gift cards if they display sufficient engagement. |
| 2-month access and direct incentive | Experimental | Behavioral: 2-month access to mental health app, Behavioral: Direct incentiveParticipants have access to the well-being app for two months, and receive a direct payment if they display sufficient engagement. |
| 4-month access and no incentive | Experimental | Behavioral: 4-month access to mental health appParticipants have access to the well-being app for four months and receive no incentive for using the app. |
| 4-month access and lottery incentive | Experimental | Behavioral: 4-month access to mental health app, Behavioral: Lottery incentiveParticipants have access to the well-being app for four months, and participate in a lottery for gift cards if they display sufficient engagement. |
| 4-month access and direct incentive | Experimental | Behavioral: Direct incentive, Behavioral: 4-month access to mental health appParticipants have access to the well-being app for four months, and receive a direct payment if they display sufficient engagement. |
| control | No intervention | –Participants do not have access to the app during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 2-month access to mental health appParticipants will have access to the well-being app for two months. | Behavioural | 2-month access and direct incentive, 2-month access and lottery incentive, 2-month access and no incentive |
| Direct incentiveA $10 gift card are given to participants at the end of the study if they used the app sufficiently. | Behavioural | 2-month access and direct incentive, 4-month access and direct incentive |
| 4-month access to mental health appParticipants will have access to the well-being app for four months. | Behavioural | 4-month access and direct incentive, 4-month access and lottery incentive, 4-month access and no incentive |
| Lottery incentiveParticipants can participate in a draw of $150 gift cards at the end of the study if they used the app sufficiently. | Behavioural | 2-month access and lottery incentive, 4-month access and lottery incentive |
Primary outcome
Depression, anxiety, and stress
Time frame: Up to six months since enrollment
Measured by the Patient Health Questionnaire 8 (PHQ)
Anxiety
Time frame: Up to six months since enrollment
Measured by GAD-7 (General Anxiety Disorder Questionnaire)
Stress
Time frame: Up to six months since enrollment
Measured by PSS-4 (Perceived Stress Scale 4)
Self-efficacy
Time frame: Up to six months since enrollment
Measured using the short version of the General Self-Efficacy Scale, the GSE-6
Locus of Control
Time frame: Up to six months since enrollment
Measure using the Internal-External Locus of Control Short Scale-4 (IE-4)
2 secondary outcomes
Remittances
Time frame: Up to six months since enrollment
Social connectedness and Integration to the US
Time frame: Up to six months since enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-month access to mental health app, Direct incentive and 4-month access to mental health app in people with Well-being and Mental Health, run by University of Texas at Austin 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?
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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raissa Fabregas (512-471-7349, rfabregas@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, anxiety, and stress (time frame: Up to six months since enrollment). The study lists 5 primary outcomes in all. 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 22 Oct 2024.