Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention

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 Overview

• Status: Recruiting
• Conditions: Well-being; Mental Health
• Intervention / Treatment: Behavioral: 2-month access to mental health app; Behavioral: Lottery incentive; Behavioral: Direct incentive; Behavioral: 4-month access to mental health app

• Study Type: Interventional
• Enrollment (Estimated): 2100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raissa Fabregas; Phone Number: 512-471-7349; Email: rfabregas@utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • The University of Texas at Austin
      • Contact: Raissa Fabregas; Phone Number: 512-471-7349; Email: rfabregas@utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2-month access and no incentive; Participants have access to the well-being app for two months and receive no incentive for using the app.	Behavioral: 2-month access to mental health app; Participants will have access to the well-being app for two months.
Experimental: 2-month access and lottery incentive; Participants have access to the well-being app for two months, and participate in a lottery for gift cards if they display sufficient engagement.	Behavioral: 2-month access to mental health app; Participants will have access to the well-being app for two months.; Behavioral: Lottery incentive; Participants can participate in a draw of $150 gift cards at the end of the study if they used the app sufficiently.
Experimental: 2-month access and direct incentive; Participants have access to the well-being app for two months, and receive a direct payment if they display sufficient engagement.	Behavioral: 2-month access to mental health app; Participants will have access to the well-being app for two months.; Behavioral: Direct incentive; A $10 gift card are given to participants at the end of the study if they used the app sufficiently.
Experimental: 4-month access and no incentive; Participants have access to the well-being app for four months and receive no incentive for using the app.	Behavioral: 4-month access to mental health app; Participants will have access to the well-being app for four months.
Experimental: 4-month access and lottery incentive; Participants have access to the well-being app for four months, and participate in a lottery for gift cards if they display sufficient engagement.	Behavioral: Lottery incentive; Participants can participate in a draw of $150 gift cards at the end of the study if they used the app sufficiently.; Behavioral: 4-month access to mental health app; Participants will have access to the well-being app for four months.
Experimental: 4-month access and direct incentive; Participants have access to the well-being app for four months, and receive a direct payment if they display sufficient engagement.	Behavioral: Direct incentive; A $10 gift card are given to participants at the end of the study if they used the app sufficiently.; Behavioral: 4-month access to mental health app; Participants will have access to the well-being app for four months.
No Intervention: control; Participants do not have access to the app during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, anxiety, and stress	Measured by the Patient Health Questionnaire 8 (PHQ)	Up to six months since enrollment
Anxiety	Measured by GAD-7 (General Anxiety Disorder Questionnaire)	Up to six months since enrollment
Stress	Measured by PSS-4 (Perceived Stress Scale 4)	Up to six months since enrollment
Self-efficacy	Measured using the short version of the General Self-Efficacy Scale, the GSE-6	Up to six months since enrollment
Locus of Control	Measure using the Internal-External Locus of Control Short Scale-4 (IE-4)	Up to six months since enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remittances	Amount and frequency of remittances to the participants' countries of origin	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)	Up to six months since enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptions and attitudes towards using mental health services	Provided that there was widespread reticence at baseline.	Up to six months since enrollment
Parental expectations and aspirations about their youngest child under 18 educational attainment	For those with children	Up to six months since enrollment
Absenteeism	Question about missing day at work in the last month	Up to six months since enrollment
Uptake for the app	Number of participants who download the app	Up to six months since enrollment
Use of the app	Number of days and minutes participants use the app	Up to six months since enrollment
Demand for the app	Willingness to pay exercise to recover demand for the app	Up to six months since enrollment

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00005337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No