Reducing Daily Stress Among Sexual and Gender Minorities
NCT ID: NCT05131360
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-01-01
2022-03-30
Brief Summary
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Detailed Description
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After providing online informed consent through REDCap, the participant will be randomized into one of the 8 mindfulness conditions, complete a 30-minute baseline survey via REDCap, and be provided with training on study protocols. Participants will engage in the study of a 5-day period (starting after the baseline survey). Participants will engage in one of 8 interventions, depending on randomization, in which participants will engage with mindfulness activities each night for a total of 5 nights which is expected to take 10-20 minutes per day (the exception to this is the control condition who only receives an introduction to mindfulness on day 1). In addition, each night over the 5-day period, participants will be sent a REDCap survey to complete a "nightly diary" which will take about 5 minutes to complete.
After completion of the 5-day protocol, participants will be scheduled for an online Zoom meeting where participants will engage in a 30-40 minute debrief interview and be renumerated. The Zoom meetings will be between a research assistant and a single participant. Lastly, in order to improve retention, RA's will perform check-in calls twice during the 5-day daily diary period.
The interventions will be administered using the multiphase optimization strategy (MOST). The participants will be randomized to at least one of the 3 intervention components of Awareness, Purpose, and Connection for this optimization study, which make up the 8 conditions. Each of these components is known to be effective in reducing stress and promoting well-being among populations that experience a high rate of discrimination (e.g., SGM). The three components are administered via the Healthy Minds Program (HMP), which is a smartphone app-based mindfulness intervention developed through the research of Dr. Richard Davidson and his team at the University of Wisconsin-Madison's Center for Healthy Minds in affiliation with the non-profit Healthy Minds Innovations (HMI). The app provides an average of 10-minute meditations that can be completed while sitting, walking, or exercising that focus on the modules of Awareness, Purpose, and Connection. Participants will log into the app and listen to the meditations that correspond to their selected randomization on each of the 5 days. The app's methodology aligns with constituents of psychological well-being that are trainable and measurable as evidenced by the Center for Healthy Minds: Awareness, Purpose, and Connection. The components are as follows: 1) Awareness through meditation promotes self-awareness, reducing the mind's ability to be distracted and instead be present at the moment. Awareness promotes well-being by bringing attention to the present moment, not allowing the mind to wander to negative thoughts that cause stress; 2) Purpose through meditation promotes mindfulness of one's thoughts and feelings in the present moment and encourages compassion with oneself and positive reappraisal; 3) Connection through meditation supports empathy, compassion, and kindness in daily activities. By shifting to this positive mindset, individuals are able to cultivate social support networks which research has found to decrease the risk for depression.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Introduction Only
This is the placebo condition in which participants engage in one day of introductory mindfulness activities.
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.
Purpose Only
Participants engage in one day of introductory mindfulness activities followed up by 5 days of purpose-based mindfulness techniques.
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.
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 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.
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 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 Only
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness-based mindfulness techniques.
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.
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 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, 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 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 and Connection
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and connection-based mindfulness techniques.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
29 Years
ALL
Yes
Sponsors
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New York University
OTHER
Responsible Party
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Principal Investigators
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Stephanie H Cook, DrPH
Role: PRINCIPAL_INVESTIGATOR
New York University
Locations
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New York University School of Global Public Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie H Cook, DrPH
Role: primary
Erica P Wood, MPH
Role: backup
References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IRB-FY2020-4338
Identifier Type: -
Identifier Source: org_study_id