Recruiting

Stress ReductionReducing Daily Stress Among Sexual and Gender Minorities

Sponsor:

New York University

Code:

NCT05131360

Conditions

Social Discrimination

Sexual and Gender Minorities

Mindfulness

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Interventions

Introduction Only

Purpose Only

Connection Only

Connection and Purpose

Awareness Only

Study Details

Brief summary:

The purpose of this study is to identify which mindfulness technique, or combination of mindfulness techniques, is most effective at mediating or eliminating stress in emerging adults who are sexual and gender as well as racial or ethnic minorities. Participants will be randomly assigned to one of eight conditions that are composed of the mindfulness techniques of Awareness, Purpose, and Connection.

Conditions

Social Discrimination

Sexual and Gender Minorities

Mindfulness

Study ID

NCT05131360

Start date

Jan 1, 2021

Status verified date

Jul, 2021

Completion date

Mar 30, 2022

Anticipated

Primary completion date

Mar 30, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Inclusion Criteria:

Between 18-29 years
Must identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
Must identify as an underrepresented racial/ethnic minority
Have an active cell phone service and be able to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
Be willing and able to receive up to 6 text messages per day
Have consistent Internet access 7 days a week between 6 p.m. and 6 a.m.
Can understand, read, and speak English
Willing to provide written informed consent.

Exclusion Criteria:

Not between 18-29 years
Does not identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
Does not identify as an underrepresented racial/ethnic minority
Does not have an active cell phone service and or ability to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
Not willing and able to receive up to 6 text messages per day
Does not have consistent Internet access 7 days a week between 6 p.m. and 6 a.m.
Does not have the ability to understand, read, and speak English
Not willing to provide written informed consent.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Introduction Only

This is the control; participants only partake in one day's worth of the introduction or foundational mindfulness activities on the HMI app.

experimental: Purpose Only

Participants partake in the introduction or foundational mindfulness for one day and then perform purpose-based mindfulness techniques for 5 days on the HMI app.

experimental: Connection Only

Participants partake in the introduction or foundational mindfulness for one day and then perform connection-based mindfulness techniques for 5 days on the HMI app.

experimental: Connection and Purpose

Participants partake in the introduction or foundational mindfulness for one day and then perform connection and purpose-based mindfulness techniques for 5 days on the HMI app.

experimental: Awareness Only

Participants partake in the introduction or foundational mindfulness for one day and then perform awareness-based mindfulness techniques for 5 days on the HMI app.

experimental: Awareness and Purpose

Participants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app.

experimental: Awareness, Purpose, and Connection

Participants partake in the introduction or foundational mindfulness for one day and then perform connection, awareness, and purpose-based mindfulness techniques for 5 days on the HMI app.

experimental: Awareness and Connection

Participants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app.

Interventions

Introduction Only

This is the placebo condition in which participants engage in one day of introductory mindfulness activities.

Purpose Only

Participants engage in one day of introductory mindfulness activities followed up by 5 days of purpose-based mindfulness techniques.

Connection Only

Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection-based mindfulness techniques.

Connection and Purpose

Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection and purpose-based mindfulness techniques.

Awareness Only

Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness-based mindfulness techniques.

Awareness and Purpose

Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and purpose-based mindfulness techniques.

Awareness, Purpose, and Connection

Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness, connection, and purpose-based mindfulness techniques

Awareness and Connection

Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and connection-based mindfulness techniques.

Primary outcome measure

Change from Baseline in Perceived Stress on the Perceived Stress Scale at Day 5 [ Time Frame: Baseline through study completion, up to one year ]
Change from Baseline in Satisfaction with Life on the Satisfaction with Life Scale at Day 5 [ Time Frame: Baseline through study completion, up to one year ]

Central Contacts and Locations

Central contacts

Stephanie H Cook, DrPH

212-992-5635 sc5810@nyu.edu

Erica P Wood, MPH

832-776-1095 ew71@nyu.edu

Locations

New York University School of Global Public Health

Recruiting

New York, New York, United States, 10003

Contacts

Stephanie H Cook, DrPH

212-992-5635 sc5810@nyu.edu

Erica P Wood, MPH

832-776-1095 ew71@nyu.edu

Principal Investigator:

Stephanie H Cook, DrPH

More Information

Sponsor

New York University

Last update posted

Nov 23, 2021

Last verified

Jul, 2021

Keywords

Social stress
Stress from discrimination
Mindfulness
Anxiety
Depression
Sexual and gender minorities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2021-11-23.