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Stress, PhysiologicalNCT04004520

Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness

A study testing Virtual Reality with Meditation in people with Stress, Physiological, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Physiological
What is being tested?
Virtual Reality with Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
24 Jul 2019to 19 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 17 years and younger
  • 25 years and older
  • non-English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the detailed description

Homeless youth experience many daily stressors, including hunger, poor sleep, harassment, and violence. Many also have been victims of child abuse and/or neglect, witnessed family and/or community violence, and/or lived in foster care prior to leaving the home setting - exposures labeled as adverse childhood experiences known to increase the risk for poor physical and mental health. Because homeless youth are often disconnected from families, friends and institutions (e.g. health care, schools, jobs), they are at greater risk for "toxic stress" resulting in impaired biological stress responses with high or low levels of the stress hormone, cortisol, and increased inflammation in the cells of the body. High levels of inflammation are associated with sickness behavior syndrome (e.g. fatigue), depression, and suicidal thoughts, which may lead youth to engage in risky behaviors (e.g. substance use, HIV risk behaviors) in an attempt to reduce symptoms. However, few studies have collected biological measures of stress among homeless youth despite prior research linking exposure to violence and trauma to impaired biological stress responses in the general population. Because homeless youth experience a greater number of adverse exposures and with higher levels of severity on a daily basis and across their lifetime than youth in the general population, our lack of understanding of the biological impact that these exposures have on homeless youths' physical and mental health in the short-term as well as across their life span limits understanding of which youth are most vulnerable to poor outcomes. This study's purpose is to test the feasibility of collecting acute and chronic stress response biomarkers in homeless youth for use with future planned research. The study will also assess 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.

Being tested
Virtual Reality with Meditation, Audio Control, Virtual reality Control
Keywords
stress, cortisol, alpha-amylase, homelessness, biomarkers, virtual reality, meditation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality with MeditationBehavioural

    Also called Guided Meditation Virtual Reality

    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).

  • Audio ControlBehavioural

    Also called UCLA Mindful App

    The UCLA Mindful App is an audio only mindfulness meditation for relaxation called Breath, Sound, Body Meditation that is 12 minutes in length.

  • Virtual reality ControlBehavioural

    Also called Looking Glass Virtual Reality

    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.

Study groups in NCT04004520
Study groupRoleWhat they receive
Virtual Reality with MeditationExperimentalParticipants will receive a virtual reality and audio guided mindfulness meditation program available at (https://guidedmeditationvr.com/)
Receives: Behavioral: Virtual Reality with Meditation
Virtual Reality ControlOtherParticipants will receive a virtual reality of historic photographs and written narratives program (https://lookingglassvr.com/)
Receives: Behavioral: Virtual reality Control
Audio ControlOtherParticipants will receive an online audio-only guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations).
Receives: Behavioral: Audio Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 5 minutes, 20 minutes, 35 minutes

Secondary outcomes (1)

  1. Change in Self-reported Anxiety as measured by the Spielberger State-Trait Anxiety Inventory

    The Spielberger State-Trait Anxiety Inventory survey which has six-item short-form of the state(STAI: Y-6 score.

    To calculate the total STAI score (range 20 - 80):

    • reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1;
    • sum all six scores;
    • multiply total score by 20/6;
    • refer to Spielberger's manuals to interpret scores (a 'normal' score is approx. 34 - 36)

    Participant will complete the survey 5 minutes prior to the intervention and then 15 minutes after the intervention.

    Measured: 5 minutes, 35 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start24 Jul 2019
  3. Primary completion8 Aug 2019
  4. Study completion19 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004520
Sponsor's protocol ID
2018H0322
Status last verified
Jul 2022
First submitted
28 Jun 2019
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32969834

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality with Meditation in people with Stress, Physiological, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Stress Reactivity (time frame: Baseline, 5 minutes, 20 minutes, 35 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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