Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness
1 other identifier
interventional
30
1 country
1
Brief Summary
The study will examine changes in acute stress (biological and psychological) via salivary cortisol and alpha amylase levels as well as survey measures of self-reported anxiety in response to either (a) a free online guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations); (b) a guided mindfulness meditation via virtual reality (https://guidedmeditationvr.com/) or (c) a virtual reality platform of historic photographs and written narratives (https://lookingglassvr.com/). Participants will also complete an interviewer administered survey to measure sociodemographic factors, mental and physical health status, substance use, and medication use and provide a hair sample to measure cortisol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedStudy Start
First participant enrolled
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2019
CompletedJuly 13, 2022
July 1, 2022
15 days
June 28, 2019
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Stress Reactivity
Participant gives the first saliva sample at arrival, then the second saliva sample 5 minutes after arrival prior to the intervention. The intervention is administered (approximately 10-15 minutes in length). The participant will give the third saliva sample immediately after the intervention and then a fourth saliva sample 15 minutes after the intervention.
Baseline, 5 minutes, 20 minutes, 35 minutes
Secondary Outcomes (1)
Change in Self-reported Anxiety as measured by the Spielberger State-Trait Anxiety Inventory
5 minutes, 35 minutes
Study Arms (3)
Virtual Reality with Meditation
EXPERIMENTALParticipants will receive a virtual reality and audio guided mindfulness meditation program available at (https://guidedmeditationvr.com/)
Virtual Reality Control
OTHERParticipants will receive a virtual reality of historic photographs and written narratives program (https://lookingglassvr.com/)
Audio Control
OTHERParticipants will receive an online audio-only guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations).
Interventions
The Guided Meditation Virtual Reality is a mindfulness meditation app provided on a virtual reality platform that includes a 10 minute audio meditation for relaxation along with a 3D visualization of natural settings (e.g. forest, beach, mountain).
The UCLA Mindful App is an audio only mindfulness meditation for relaxation called Breath, Sound, Body Meditation that is 12 minutes in length.
The Looking Glass Virtual Reality is a stereographic 3D photo viewer provided on a virtual reality platform featuring photos from around the world dating back to approximately a century ago that participants will view for 10 minutes.
Eligibility Criteria
You may qualify if:
- Between the ages of 18 to 24 years
- Meets the criteria for homelessness as defined by the federal McKinney-Vento Act as "lacking a fixed, regular, stable, and adequate nighttime residence" and includes "living in a publicly or privately operated shelter designed to provide temporary living accommodations, or a public or private place not designed for, or ordinarily used as, regular sleeping accommodations for human beings"
- speaks and understands the English language
You may not qualify if:
- years and younger
- years and older
- non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
Related Publications (1)
Chavez LJ, Kelleher K, Slesnick N, Holowacz E, Luthy E, Moore L, Ford J. Virtual Reality Meditation Among Youth Experiencing Homelessness: Pilot Randomized Controlled Trial of Feasibility. JMIR Ment Health. 2020 Sep 24;7(9):e18244. doi: 10.2196/18244.
PMID: 32969834DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jodi L Ford, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 2, 2019
Study Start
July 24, 2019
Primary Completion
August 8, 2019
Study Completion
August 19, 2019
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share