Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04004520
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2019-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stress Reactivity', 'timeFrame': 'Baseline, 5 minutes, 20 minutes, 35 minutes', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Self-reported Anxiety as measured by the Spielberger State-Trait Anxiety Inventory', 'timeFrame': '5 minutes, 35 minutes', 'description': "The Spielberger State-Trait Anxiety Inventory survey which has six-item short-form of the state(STAI: Y-6 score.\n\nTo calculate the total STAI score (range 20 - 80):\n\n* reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1;\n* sum all six scores;\n* multiply total score by 20/6;\n* refer to Spielberger's manuals to interpret scores (a 'normal' score is approx. 34 - 36)\n\nParticipant will complete the survey 5 minutes prior to the intervention and then 15 minutes after the intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'cortisol', 'alpha-amylase', 'homelessness', 'biomarkers', 'virtual reality', 'meditation'], 'conditions': ['Stress, Physiological']}, 'referencesModule': {'references': [{'pmid': '32969834', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://guidedmeditationvr.com', 'label': 'Guided Meditation VR'}, {'url': 'https://lookingglassvr.com/', 'label': 'Looking Glass VR'}, {'url': 'https://www.uclahealth.org/marc/mindful-meditations', 'label': 'UCLA Mindful Meditation'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 to 24 years\n* 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"\n* speaks and understands the English language\n\nExclusion Criteria:\n\n* 17 years and younger\n* 25 years and older\n* non-English speakers'}, 'identificationModule': {'nctId': 'NCT04004520', 'briefTitle': 'Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness', 'orgStudyIdInfo': {'id': '2018H0322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality with Meditation', 'description': 'Participants will receive a virtual reality and audio guided mindfulness meditation program available at (https://guidedmeditationvr.com/)', 'interventionNames': ['Behavioral: Virtual Reality with Meditation']}, {'type': 'OTHER', 'label': 'Virtual Reality Control', 'description': 'Participants will receive a virtual reality of historic photographs and written narratives program (https://lookingglassvr.com/)', 'interventionNames': ['Behavioral: Virtual reality Control']}, {'type': 'OTHER', 'label': 'Audio Control', 'description': 'Participants will receive an online audio-only guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations).', 'interventionNames': ['Behavioral: Audio Control']}], 'interventions': [{'name': 'Virtual Reality with Meditation', 'type': 'BEHAVIORAL', 'otherNames': ['Guided Meditation Virtual Reality'], 'description': '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).', 'armGroupLabels': ['Virtual Reality with Meditation']}, {'name': 'Audio Control', 'type': 'BEHAVIORAL', 'otherNames': ['UCLA Mindful App'], 'description': 'The UCLA Mindful App is an audio only mindfulness meditation for relaxation called Breath, Sound, Body Meditation that is 12 minutes in length.', 'armGroupLabels': ['Audio Control']}, {'name': 'Virtual reality Control', 'type': 'BEHAVIORAL', 'otherNames': ['Looking Glass Virtual Reality'], 'description': '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.', 'armGroupLabels': ['Virtual Reality Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jodi L Ford, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}