Reducing Daily Stress Among Sexual and Gender Minorities
REDUCE
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedNovember 23, 2021
July 1, 2021
1.2 years
October 5, 2021
November 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Perceived Stress on the Perceived Stress Scale at Day 5
The primary outcome for this study is change in perceived stress as measured by the Perceived Stress Scale from baseline to Day 5 among all study participants.
Baseline through study completion, up to one year
Change from Baseline in Satisfaction with Life on the Satisfaction with Life Scale at Day 5
The primary outcome for this study is change in perceived satisfaction with life as measured by the Satisfaction with Life Scale from baseline to Day 5 among all study participants.
Baseline through study completion, up to one year
Secondary Outcomes (1)
Optimized Intervention Package
Through study completion, an average of 1 year
Study Arms (8)
Introduction Only
PLACEBO COMPARATORThis is the control; participants only partake in one day's worth of the introduction or foundational mindfulness activities on the HMI app.
Purpose Only
EXPERIMENTALParticipants partake in the introduction or foundational mindfulness for one day and then perform purpose-based mindfulness techniques for 5 days on the HMI app.
Connection Only
EXPERIMENTALParticipants partake in the introduction or foundational mindfulness for one day and then perform connection-based mindfulness techniques for 5 days on the HMI app.
Connection and Purpose
EXPERIMENTALParticipants 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.
Awareness Only
EXPERIMENTALParticipants partake in the introduction or foundational mindfulness for one day and then perform awareness-based mindfulness techniques for 5 days on the HMI app.
Awareness and Purpose
EXPERIMENTALParticipants 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.
Awareness, Purpose, and Connection
EXPERIMENTALParticipants 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.
Awareness and Connection
EXPERIMENTALParticipants 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
This is the placebo condition in which participants engage in one day of introductory mindfulness activities.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of purpose-based mindfulness techniques.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection-based mindfulness techniques.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection and purpose-based mindfulness techniques.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness-based mindfulness techniques.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and purpose-based mindfulness techniques.
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness, connection, and purpose-based mindfulness techniques
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and connection-based mindfulness techniques.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Global Public Health
New York, New York, 10003, United States
Related Publications (1)
Cook SH, Wood EP, Mirin N, Bandel M, Delorme M, Gad L, Jayakar O, Mustafa Z, Tatar R, Javdani S, Godfrey E. A Mindfulness-Based Intervention to Alleviate Stress From Discrimination Among Young Sexual and Gender Minorities of Color: Protocol for a Pilot Optimization Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e35593. doi: 10.2196/35593.
PMID: 34928237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie H Cook, DrPH
New York University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
November 23, 2021
Study Start
January 1, 2021
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
November 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share
N/A (not to be shared with other researchers)