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

NCT06652711 | Recruiting

• 1 other identifier: STUDY00005337
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Well-being; Mental Health

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Remittances

  Up to six months since enrollment

• Social connectedness and Integration to the US

  Up to six months since enrollment

Other Outcomes (6)

• Perceptions and attitudes towards using mental health services

  Up to six months since enrollment

• Parental expectations and aspirations about their youngest child under 18 educational attainment

  Up to six months since enrollment

• Absenteeism

  Up to six months since enrollment

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Interventions

2-month access to mental health app BEHAVIORAL

Participants will have access to the well-being app for two months.

2-month access and direct incentive; 2-month access and lottery incentive; 2-month access and no incentive

Direct incentive BEHAVIORAL

A $10 gift card are given to participants at the end of the study if they used the app sufficiently.

2-month access and direct incentive; 4-month access and direct incentive

4-month access to mental health app BEHAVIORAL

Participants will have access to the well-being app for four months.

4-month access and direct incentive; 4-month access and lottery incentive; 4-month access and no incentive

Lottery incentive BEHAVIORAL

Participants can participate in a draw of $150 gift cards at the end of the study if they used the app sufficiently.

2-month access and lottery incentive; 4-month access and lottery incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Raissa Fabregas

CONTACT

512-471-7349; rfabregas@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: September 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)