- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05766852
Potentielle fordele ved den somatiske psykoedukative intervention
Potentielle fordele ved den somatiske psykoedukative intervention til forbedring af sundhedsudbyderes sundhed og velvære
Målet med dette kliniske forsøg er at udforske mulige fordele og mekanismer, hvorigennem Somatic Psychoeducational Intervention kan forbedre sundhed og velvære hos sundhedsudbydere (HCP). Hovedmålene med undersøgelsen er:
- At forstå, hvordan deltagerne klarer sig med hensyn til deres mindfulness, mestringsadfærd, følelsesmæssig, fysisk og arbejdsmæssig sundhed og autonom reaktivitet (graden deltagerne fysiologisk reagerer).
- At undersøge, om præ-interventionsforanstaltninger relaterer sig til HCP'ernes overordnede funktion.
- For at bestemme 1-uges og 1-måned post-interventionens virkninger af interventionen(erne)
- At identificere individuelle karakteristika, der påvirker effektiviteten af interventionen ved 1-uges og 1-måneds post-interventionsvurderinger.
Deltagerne vil:
- gennemføre online forhåndsvurderingsforanstaltninger vedrørende, hvordan de klarer sig følelsesmæssigt og med hensyn til deres arbejdssituation.
- komplet præ-intervention, 1-uge post-intervention og 1-måned post-intervention vurderinger, der involverer færdiggørelse af online-foranstaltninger og præ-intervention og 1-uge post-intervention vurderinger, der involverer indsamling af blodprøver.
- deltog i interventionen (som involverer 6 timer; 2-timers undervisningen vil blive administreret over tre uger).
Forskere vil sammenligne Intervention First Group med Group Intervention Second for at se, om Intervention First Group oplever større forbedringer i deres sundhed og velvære.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Det er hensigten med dette forslag at eksperimentelt udforske de mulige fordele og mekanismer, hvorigennem den somatiske psykoedukative intervention hos sundhedsudbydere (HCP) kan påvirke følelsesmæssig og fysisk sundhed og autonom og neuroendokrin funktion. Dette vil blive opnået af vores team ved at bruge velvaliderede selvrapporteringsmålinger af mental sundhed og autonom reaktivitet og ikke-invasive målinger af niveauer af oxytocin og vasopressin.
Specifikke mål:
- Specifikt mål 1: At forstå via screening online-vurderingen, hvordan deltagerne klarer sig med hensyn til deres opmærksomhed, mestringsadfærd, følelsesmæssige, fysiske og arbejdsmæssige sundhed og selvrapporterede autonome reaktivitet
- Specifikt mål 2: At undersøge om præ-interventionsmålinger af ANS-reaktivitet og neuropeptiderne oxytocin/vasopressin relaterer sig til HCP'ernes overordnede funktion.
- Specifikt mål 3: At afgøre, om interventionen fører til forbedringer i funktion 1 uge og 1 måned efter interventionen
- Specifikt mål 4: At identificere individuelle karakteristika, der påvirker effektiviteten af interventionen 1 uge og 1 måned efter intervention.
Eksperimentelt design
- I screeningsfasen vil vi rekruttere sundhedsudbydere, begyndende med sengesygeplejersker. Vi vil stille et link til undersøgelsen til rådighed, så deltagerne kan gennemføre online forhåndsvurderingsforanstaltninger vedrørende, hvordan de klarer sig følelsesmæssigt og med hensyn til deres arbejdssituation. Disse oplysninger vil blive brugt til at beregne den samlede nødscore og bestemme, hvem der skal inviteres til interventionsfasen.
- I interventionsfasen vil deltagerne blive tilfældigt fordelt af en tilfældig talgenerator til to grupper. Intervention First Group, som vil blive stillet til rådighed for interventionen i den første session, og Intervention Second Group, som vil fungere som ventelistekontrolgruppen og få interventionen i den anden session.
- De inviterede deltagere vil gennemføre vurderinger 1 uge før påbegyndelse af vurderingen og 1 uge efter interventionen, der involverer onlinemåling og indsamling af blodprøver.
- Den Somatiske Psykoeducative Intervention vil blive givet i tre 2-timers klasser, og deltagerne vil blive belønnet for deres deltagelse økonomisk og gennem efteruddannelse.
- Derudover vil deltagerne gennemføre den online 1-måneds post-intervention vurdering
Analyser mellem emner vil sammenligne data fra session 1 for at afgøre, om deltagerne i Intervention First Group udviser større forbedringer end deltagerne i Intervention Second Group B, som vil fungere som kontrolgruppen på dette tidspunkt. Analyser af gentagne foranstaltninger inden for emnet vil bestemme de potentielle fordele ved interventionen for alle deltagere ved at sammenligne deres funktion på de forskellige tidspunkter.
- For resultatmålene vil ændringsscore blive beregnet for at bestemme ændringen fra præ-interventionen til 1-uges post-interventionsvurderingen og fra 1-uges post-interventionsvurderingen til 1-måneds post-interventionsvurderingen. Disse ændringers score vil blive brugt til at bestemme, om der er præ-interventionsfaktorer, der påvirker interventionens succes.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Jacksonville, Florida, Forenede Stater, 32209
- UF Health Jacksonville
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Enkeltpersoner er berettiget til at deltage i screeningsfasen af undersøgelsen, hvis de er mindst 18 år gamle og er sengesygeplejersker i enheder på 8th street placering af UF Health.
- Fokus på 8th Street placeringen, så det er nemmere at få blodprøverne fra sygeplejerskerne. Dermed udelukker vi i første omgang sygeplejersker fra de øvrige UF Sundhedssteder.
Ekskluderingskriterier:
- De data, der er opnået under screeningsfasen, vil blive downloadet og flyttet til SPSS for at beregne en total distress-score, som er en kombination af deres emotionelle distress-score (kombination af scores for målinger, der vurderer depression, angst og PTSD-symptomer) og fysiske distress-scores ( kombination af autonom reaktivitet og fysiske symptomer).
- Total distress score vil blive brugt til at bestemme de deltagere, der kæmper mest, som til gengæld har størst sandsynlighed for at få gavn af den somatiske psykoedukative intervention.
- Forskere vil bruge de samlede distress-scores til at bestemme de 70 til 80 deltagere, der vil blive inviteret til interventionsfasen, dem med den højeste samlede distress-score vil blive inviteret til at deltage.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Gruppe A: Åndedræt + Psykoedukation
Deltagerne vil blive bedt om at deltage i de 3 1,5-timers interventionsklasser.
Pre-intervention og post-intervention vurderinger vil kræve, at deltagerne udfylder en 20-25-minutters online-undersøgelse via Qualtrics og giver spytprøver.
|
Deltagerne vil arbejde på at øge kropsbevidstheden ved at lære psykoedukation, bevægelsesteknikker og afspænding.
|
Eksperimentel: Gruppe B: Åndedræt + Bevægelse + Psykoedukation
Deltagerne vil blive bedt om at deltage i de 3 1,5-timers interventionsklasser.
Pre-intervention og post-intervention vurderinger vil kræve, at deltagerne udfylder en 20-25-minutters online-undersøgelse via Qualtrics og giver spytprøver.
|
Deltagerne vil arbejde på at øge kropsbevidstheden ved at lære psykoedukation, bevægelsesteknikker og afspænding.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Måling af ændring i depressive symptomer ved hjælp af patientsundhedsspørgeskemaet (PHQ-8) selvrapporterende spørgeskema.
Tidsramme: Baseline op til 1 måned (efter intervention)
|
Patient Health Questionnaire-depressionsskalaen med otte punkter (PHQ-8) vil blive brugt til at vurdere den aktuelle depression.
Depression kan defineres som vedvarende følelser af tristhed eller tab af interesse for typiske behagelige aktiviteter.
Dette mål omfatter 8 punkter, der besvares via en 4-punkts Likert-skala (0 = slet ikke, 1 = flere dage, 2 = mere end halvdelen af dagene og 3 - næsten hver dag).
Samlet score spænder fra 0 til 24, med højere indikerede flere symptomer på depression.
|
Baseline op til 1 måned (efter intervention)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lourdes P Dale, PhD, University of Florida
Publikationer og nyttige links
Generelle publikationer
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
- Porges SW. The polyvagal perspective. Biol Psychol. 2007 Feb;74(2):116-43. doi: 10.1016/j.biopsycho.2006.06.009. Epub 2006 Oct 16.
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Porges SW. The polyvagal theory: phylogenetic substrates of a social nervous system. Int J Psychophysiol. 2001 Oct;42(2):123-46. doi: 10.1016/s0167-8760(01)00162-3.
- Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189. Erratum In: J Altern Complement Med. 2005 Apr;11(2):383-4.
- Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.
- Cochran DM, Fallon D, Hill M, Frazier JA. The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings. Harv Rev Psychiatry. 2013 Sep-Oct;21(5):219-47. doi: 10.1097/HRP.0b013e3182a75b7d.
- Minassian A, Maihofer AX, Baker DG, Nievergelt CM, Geyer MA, Risbrough VB; Marine Resiliency Study Team. Association of Predeployment Heart Rate Variability With Risk of Postdeployment Posttraumatic Stress Disorder in Active-Duty Marines. JAMA Psychiatry. 2015 Oct;72(10):979-86. doi: 10.1001/jamapsychiatry.2015.0922.
- Price CJ, Hooven C. Interoceptive Awareness Skills for Emotion Regulation: Theory and Approach of Mindful Awareness in Body-Oriented Therapy (MABT). Front Psychol. 2018 May 28;9:798. doi: 10.3389/fpsyg.2018.00798. eCollection 2018.
- Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.
- van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- Meyer-Lindenberg A, Domes G, Kirsch P, Heinrichs M. Oxytocin and vasopressin in the human brain: social neuropeptides for translational medicine. Nat Rev Neurosci. 2011 Aug 19;12(9):524-38. doi: 10.1038/nrn3044.
- Price M, Szafranski DD, van Stolk-Cooke K, Gros DF. Investigation of abbreviated 4 and 8 item versions of the PTSD Checklist 5. Psychiatry Res. 2016 May 30;239:124-30. doi: 10.1016/j.psychres.2016.03.014. Epub 2016 Mar 8.
- Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023. Erratum In: Mayo Clin Proc. 2016 Feb;91(2):276.
- Brown RP, Gerbarg PL. Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. J Altern Complement Med. 2005 Aug;11(4):711-7. doi: 10.1089/acm.2005.11.711.
- Halpern SD, Karlawish JH, Casarett D, Berlin JA, Asch DA. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med. 2004 Apr 12;164(7):801-3. doi: 10.1001/archinte.164.7.801.
- Alleyne S, Dale L, Robertson-Blackmore E, Kishore A, Cuffe S, Fallucco E. United States of America Child and Adolescent Psychiatrists' Career Satisfaction by Career Stage. Acad Psychiatry. 2022 Aug;46(4):441-450. doi: 10.1007/s40596-021-01577-x. Epub 2022 Jan 16.
- Barello S, Palamenghi L, Graffigna G. Burnout and somatic symptoms among frontline healthcare professionals at the peak of the Italian COVID-19 pandemic. Psychiatry Res. 2020 Aug;290:113129. doi: 10.1016/j.psychres.2020.113129. Epub 2020 May 27.
- Baribeau DA, Anagnostou E. Oxytocin and vasopressin: linking pituitary neuropeptides and their receptors to social neurocircuits. Front Neurosci. 2015 Sep 24;9:335. doi: 10.3389/fnins.2015.00335. eCollection 2015.
- Cabrera A, Kolacz J, Pailhez G, Bulbena-Cabre A, Bulbena A, Porges SW. Assessing body awareness and autonomic reactivity: Factor structure and psychometric properties of the Body Perception Questionnaire-Short Form (BPQ-SF). Int J Methods Psychiatr Res. 2018 Jun;27(2):e1596. doi: 10.1002/mpr.1596. Epub 2017 Nov 28.
- Carter CS, Kenkel WM, MacLean EL, Wilson SR, Perkeybile AM, Yee JR, Ferris CF, Nazarloo HP, Porges SW, Davis JM, Connelly JJ, Kingsbury MA. Is Oxytocin "Nature's Medicine"? Pharmacol Rev. 2020 Oct;72(4):829-861. doi: 10.1124/pr.120.019398.
- Carter CS, Grippo AJ, Pournajafi-Nazarloo H, Ruscio MG, Porges SW. Oxytocin, vasopressin and sociality. Prog Brain Res. 2008;170:331-6. doi: 10.1016/S0079-6123(08)00427-5.
- Carter CS. Oxytocin pathways and the evolution of human behavior. Annu Rev Psychol. 2014;65:17-39. doi: 10.1146/annurev-psych-010213-115110. Epub 2013 Sep 19.
- Carter CS, Pournajafi-Nazarloo H, Kramer KM, Ziegler TE, White-Traut R, Bello D, Schwertz D. Oxytocin: behavioral associations and potential as a salivary biomarker. Ann N Y Acad Sci. 2007 Mar;1098:312-22. doi: 10.1196/annals.1384.006.
- Cash M, Whittingham K. What facets of mindfulness contribute to psychological well-being and depressive, anxious, and stress-related symptomatology? Mindfulness. 2010;1(3):177-182.
- Champely, S. (2020). Basic Functions for Power Analysis. R package version 1.3-0, https://CRAN.R-project.org/package=pwr.
- Coffey KA, Hartman M. Mechanisms of action in the inverse relationship between mindfulness and psychological distress. Complement Health Pract Rev. 2008;13(2):79-91.
- Dale LP, Bossemeyer Biernacki N, Nunez LV, Herman MS, Turpeau MC, Lange LJ. Factors affecting emotional distress in college students during COVID-19. Manuscript under review by the Journal of American College Health. 2022.
- Dale LP, Carroll LE, Galen G, Hayes JA, Webb KW, Porges SW. Abuse history is related to autonomic regulation to mild exercise and psychological wellbeing. Appl Psychophysiol Biofeedback. 2009 Dec;34(4):299-308. doi: 10.1007/s10484-009-9111-4. Epub 2009 Aug 26.
- Dale LP, Cuffe SP, Sambuco N, Guastello AD, Leon KG, Nunez LV, Bhullar A, Allen BR, Mathews CA. Morally Distressing Experiences, Moral Injury, and Burnout in Florida Healthcare Providers during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Nov 24;18(23):12319. doi: 10.3390/ijerph182312319.
- Dale LP, Cuffe SP, Kolacz J, Leon KG, Bossemeyer Biernacki N, Bhullar A, Nix EJ, Porges SW. Increased Autonomic Reactivity and Mental Health Difficulties in COVID-19 Survivors: Implications for Medical Providers. Front Psychiatry. 2022 May 25;13:830926. doi: 10.3389/fpsyt.2022.830926. eCollection 2022.
- Dale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.
- Dale LP, Fasciano LC, Shaikh SK, Little Hodge AL, Gracia B, Majdick JM, et al. Maltreatment History and Physiological Regulation in Response to Physical and Emotional Stressors. In S. W. Porges, L. P. Dale, & J. Kolacz. Trauma through the lens of the Polyvagal Theory: Implications for understanding mechanisms and optimizing outcomes. Workshop presentation at 25th Annual International Trauma Conference, Boston, MA.
- Dale LP, Shaikh SK, Fasciano LC, Watorek VD, Heilman KJ, Porges SW. College females with maltreatment histories have atypical autonomic regulation and poor psychological wellbeing. Psychol Trauma. 2018 Jul;10(4):427-434. doi: 10.1037/tra0000342. Epub 2017 Nov 20.
- Doussard-Roosevelt JA, Porges SW. The role of neurobehavioral organization in stress responses: A polyvagal model. 1999.
- Ellis BJ, Horn AJ, Carter CS, van IJzendoorn MH, Bakermans-Kranenburg MJ. Developmental programming of oxytocin through variation in early-life stress: Four meta-analyses and a theoretical reinterpretation. Clin Psychol Rev. 2021 Jun;86:101985. doi: 10.1016/j.cpr.2021.101985. Epub 2021 Feb 15.
- Figueroa MA, Demeersman RE, Manning J. The autonomic and rate pressure product responses of tai chi practitioners. N Am J Med Sci. 2012 Jun;4(6):270-5. doi: 10.4103/1947-2714.97208.
- Friedman MJ. Acknowledging the psychiatric cost of war. N Engl J Med. 2004 Jul 1;351(1):75-7. doi: 10.1056/NEJMe048129. No abstract available.
- Goelz DV. Tai chi and its effect on post-traumatic stress. Doctoral thesis. The Chicago School of Professional Psychology; 2015
- Grahn P, Ottosson J, Uvnas-Moberg K. The Oxytocinergic System as a Mediator of Anti-stress and Instorative Effects Induced by Nature: The Calm and Connection Theory. Front Psychol. 2021 Jul 5;12:617814. doi: 10.3389/fpsyg.2021.617814. eCollection 2021.
- Grodin MA, Piwowarczyk L, Fulker D, Bazazi AR, Saper RB. Treating survivors of torture and refugee trauma: a preliminary case series using qigong and t'ai chi. J Altern Complement Med. 2008 Sep;14(7):801-6. doi: 10.1089/acm.2007.0736.
- Groenewegen PP, Gress S, Schafer W. General Practitioners' Participation in a Large, Multicountry Combined General Practitioner-Patient Survey: Recruitment Procedures and Participation Rate. Int J Family Med. 2016;2016:4929432. doi: 10.1155/2016/4929432. Epub 2016 Mar 7.
- Groth SW. Honorarium or coercion: use of incentives for participants in clinical research. J N Y State Nurses Assoc. 2010 Spring-Summer;41(1):11-3; quiz 22.
- Holst Y, Thorell LB. Adult executive functioning inventory (ADEXI): Validity, reliability, and relations to ADHD. Int J Methods Psychiatr Res. 2018 Mar;27(1):e1567. doi: 10.1002/mpr.1567. Epub 2017 May 12.
- Holst Y, Thorell LB. Neuropsychological Functioning in Adults With ADHD and Adults With Other Psychiatric Disorders. J Atten Disord. 2017 Jan;21(2):137-148. doi: 10.1177/1087054713506264. Epub 2016 Jul 28.
- Hruska B, Barduhn MS. Dynamic psychosocial risk and protective factors associated with mental health in Emergency Medical Service (EMS) personnel. J Affect Disord. 2021 Mar 1;282:9-17. doi: 10.1016/j.jad.2020.12.130. Epub 2020 Dec 28.
- Jones JL, Ackerman D, Barona J, Calle M, Andersen CJ, Kim JE, Volek JS, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean low-glycemic-load diet alone or in combination with a medical food improves insulin sensitivity and reduces inflammation in women with metabolic syndrome. British Journal of Medicine & Medical Research. 2011;1(4).
- Jones JL, Comperatore M, Barona J, Calle MC, Andersen C, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet decreases atherogenic lipoproteins and reduces lipoprotein (a) and oxidized low-density lipoprotein in women with metabolic syndrome. Metabolism. 2012 Mar;61(3):366-72. doi: 10.1016/j.metabol.2011.07.013. Epub 2011 Sep 23.
- Joyce S, Shand F, Lal TJ, Mott B, Bryant RA, Harvey SB. Resilience@Work Mindfulness Program: Results From a Cluster Randomized Controlled Trial With First Responders. J Med Internet Res. 2019 Feb 19;21(2):e12894. doi: 10.2196/12894.
- Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.
- Khalsa SS, Lapidus RC. Can Interoception Improve the Pragmatic Search for Biomarkers in Psychiatry? Front Psychiatry. 2016 Jul 25;7:121. doi: 10.3389/fpsyt.2016.00121. eCollection 2016.
- Keck ME. Corticotropin-releasing factor, vasopressin and receptor systems in depression and anxiety. Amino Acids. 2006 Oct;31(3):241-50. doi: 10.1007/s00726-006-0333-y. Epub 2006 May 29.
- Kumsta R, Heinrichs M. Oxytocin, stress and social behavior: neurogenetics of the human oxytocin system. Curr Opin Neurobiol. 2013 Feb;23(1):11-6. doi: 10.1016/j.conb.2012.09.004. Epub 2012 Oct 4.
- Kolacz J, Dale LP, Nix EJ, Roath OK, Lewis GF, Porges SW. Adversity History Predicts Self-Reported Autonomic Reactivity and Mental Health in US Residents During the COVID-19 Pandemic. Front Psychiatry. 2020 Oct 27;11:577728. doi: 10.3389/fpsyt.2020.577728. eCollection 2020.
- Lahn MJ. Indices of heart rate variability and compassion in healthcare professionals following stress resilience training [ProQuest Information & Learning]. In Dissertation Abstracts International: Section B: The Sciences and Engineering (Vol. 75, Issue 11-B(E)). 2015
- Lan C. Tai chi improves natural harmony in autonomic function. N Am J Med Sci. 2012 Jun;4(6):276-7. No abstract available.
- Lawn S, Roberts L, Willis E, Couzner L, Mohammadi L, Goble E. The effects of emergency medical service work on the psychological, physical, and social well-being of ambulance personnel: a systematic review of qualitative research. BMC Psychiatry. 2020 Jul 3;20(1):348. doi: 10.1186/s12888-020-02752-4.
- Leavitt, K.S. Pat Ogden, Kekuni Minton and Clare Pain, Trauma and the body: A sensorimotor approach to psychotherapy. Clin Soc Work J. 2008;36:221-223.
- Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11.
- McDonald MA, Yang Y, Lancaster CL. The association of distress tolerance and mindful awareness with mental health in first responders. Psychol Serv. 2022;19(Suppl 1):34-44. doi: 10.1037/ser0000588. Epub 2021 Oct 28.
- Morton L, Cogan N, Kolacz J, Calderwood C, Nikolič M, Bacon T, et al. Developing a standardised measure of psychological safety. 35th Annual Conference of the European Health Psychology Society.2021
- Mosheva M, Gross R, Hertz-Palmor N, Hasson-Ohayon I, Kaplan R, Cleper R, Kreiss Y, Gothelf D, Pessach IM. The association between witnessing patient death and mental health outcomes in frontline COVID-19 healthcare workers. Depress Anxiety. 2021 Apr;38(4):468-479. doi: 10.1002/da.23140. Epub 2021 Feb 5.
- Nash WP, Marino Carper TL, Mills MA, Au T, Goldsmith A, Litz BT. Psychometric evaluation of the Moral Injury Events Scale. Mil Med. 2013 Jun;178(6):646-52. doi: 10.7205/MILMED-D-13-00017.
- Neumann ID, Landgraf R. Balance of brain oxytocin and vasopressin: implications for anxiety, depression, and social behaviors. Trends Neurosci. 2012 Nov;35(11):649-59. doi: 10.1016/j.tins.2012.08.004. Epub 2012 Sep 11.
- Norman SB, Feingold JH, Kaye-Kauderer H, Kaplan CA, Hurtado A, Kachadourian L, Feder A, Murrough JW, Charney D, Southwick SM, Ripp J, Peccoralo L, Pietrzak RH. Moral distress in frontline healthcare workers in the initial epicenter of the COVID-19 pandemic in the United States: Relationship to PTSD symptoms, burnout, and psychosocial functioning. Depress Anxiety. 2021 Oct;38(10):1007-1017. doi: 10.1002/da.23205. Epub 2021 Jul 22.
- Papazoglou K. The examination of different pathways leading towards police traumatization: Exploring the role of moral injury and personality in police compassion fatigue [ProQuest Information & Learning]. In Dissertation Abstracts International: Section B: The Sciences and Engineering (Vol. 79, Issue 3-B(E)). 2018
- Perez LG, Abrams MP, Lopez-Martinez AE, Asmundson GJ. Trauma exposure and health: the role of depressive and hyperarousal symptoms. J Trauma Stress. 2012 Dec;25(6):641-8. doi: 10.1002/jts.21762. Epub 2012 Nov 26.
- Phillips KFV, Power MJ. A new self-report measure of emotion regulation in adolescents: The Regulation of Emotions Questionnaire, Clin Psychol Psychother. 2007;14(2):145-156.
- Porges SW. Neuroception: A subconscious system for detecting threats and safety. Zero Three. 2004; 24(5):19-24.
- Porges, SW. Polyvagal Safety: Attachment, Communication, Self-Regulation. WW Norton & Company; 2021.
- Porges SW. Stress and parasympathetic control. Stress science: neuroendocrinology. 2010 Apr 6:306-12.2010
- Porges SW. Body Perception Questionnaire Short Form© 1993, 2015
- Porges SW. The polyvagal theory: neurophysiological foundations of emotions, attachment, communication, and self-regulation (Norton Series on Interpersonal Neurobiology). WW Norton & Company; 2011 Apr 25.
- Porges SW. The Polyvagal Theory: phylogenetic contributions to social behavior. Physiol Behav. 2003 Aug;79(3):503-13. doi: 10.1016/s0031-9384(03)00156-2.
- Romano A, Tempesta B, Micioni Di Bonaventura MV, Gaetani S. From Autism to Eating Disorders and More: The Role of Oxytocin in Neuropsychiatric Disorders. Front Neurosci. 2016 Jan 12;9:497. doi: 10.3389/fnins.2015.00497. eCollection 2015.
- Russell ML, Moralejo DG, Burgess ED. Paying research subjects: participants' perspectives. J Med Ethics. 2000 Apr;26(2):126-30. doi: 10.1136/jme.26.2.126.
- Sayer NA, Spoont M, Murdoch M, Parker LE, Hintz S, Rosenheck R. A qualitative study of U.S. veterans' reasons for seeking Department of Veterans Affairs disability benefits for posttraumatic stress disorder. J Trauma Stress. 2011 Dec;24(6):699-707. doi: 10.1002/jts.20693. Epub 2011 Nov 22.
- Schmid RF, Thomas J. The interactive effects of heart rate variability and mindfulness on indicators of well-being in healthcare professionals' daily working life. Int J Psychophysiol. 2021 Jun;164:130-138. doi: 10.1016/j.ijpsycho.2021.01.012. Epub 2021 Feb 3.
- Schoniger C, Braun D, Siepmann M, Petrowski K. Comparison of the HRV of Emergency Physicians in the HEMS During Helicopter Operations: Analysis of Differences as a Function of Number of Operations and Workload. Appl Psychophysiol Biofeedback. 2020 Dec;45(4):249-257. doi: 10.1007/s10484-020-09480-1.
- Schulz-Heik RJ, Meyer H, Mahoney L, Stanton MV, Cho RH, Moore-Downing DP, Avery TJ, Lazzeroni LC, Varni JM, Collery LM, Bayley PJ. Results from a clinical yoga program for veterans: yoga via telehealth provides comparable satisfaction and health improvements to in-person yoga. BMC Complement Altern Med. 2017 Apr 4;17(1):198. doi: 10.1186/s12906-017-1705-4.
- Shin HJ, Rosen CS, Greenbaum MA, Jain S. Longitudinal correlates of aggressive behavior in help-seeking U.S. veterans with PTSD. J Trauma Stress. 2012 Dec;25(6):649-56. doi: 10.1002/jts.21761.
- Slattery DA, Neumann ID. Oxytocin and Major Depressive Disorder: Experimental and Clinical Evidence for Links to Aetiology and Possible Treatment. Pharmaceuticals (Basel). 2010 Mar 16;3(3):702-724. doi: 10.3390/ph3030702.
- Van der Kolk, B. Posttraumatic therapy in the age of neuroscience. Psychoanalytic dialogues. 2002;12(3): 381-392.
- Wagner SL, White N, Fyfe T, Matthews LR, Randall C, Regehr C, White M, Alden LE, Buys N, Carey MG, Corneil W, Fraess-Phillips A, Krutop E, Fleischmann MH. Systematic review of posttraumatic stress disorder in police officers following routine work-related critical incident exposure. Am J Ind Med. 2020 Jul;63(7):600-615. doi: 10.1002/ajim.23120. Epub 2020 May 17.
- Wang WC, Zhang AL, Rasmussen B, Lin LW, Dunning T, Kang SW, Park BJ, Lo SK. The effect of Tai Chi on psychosocial well-being: a systematic review of randomized controlled trials. J Acupunct Meridian Stud. 2009 Sep;2(3):171-81. doi: 10.1016/S2005-2901(09)60052-2.
- White-Traut R, Watanabe K, Pournajafi-Nazarloo H, Schwertz D, Bell A, Carter CS. Detection of salivary oxytocin levels in lactating women. Dev Psychobiol. 2009 May;51(4):367-73. doi: 10.1002/dev.20376.
- Guastello AD, Brunson JC, Sambuco N, Dale LP, Tracy NA, Allen BR, Mathews CA. Predictors of professional burnout and fulfilment in a longitudinal analysis on nurses and healthcare workers in the COVID-19 pandemic. J Clin Nurs. 2024 Jan;33(1):288-303. doi: 10.1111/jocn.16463. Epub 2022 Aug 10.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB202200233
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Arbejdsrelateret stress
-
Riyadh Elm UniversityAfsluttetOral Health Related Quality of Life OHRQoLSaudi Arabien
-
University of MalayaUkendtTranspalatal bue (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Ortodontiske smerter | Tredimensionel (3D) ortodontisk enhedMalaysia
-
National Human Genome Research Institute (NHGRI)Children's National Research Institute; Uniformed Services University of...RekrutteringProteus syndrom | PIK3CA Related Overgrowth SpectrumForenede Stater
Kliniske forsøg med Somatisk psykoedukationel intervention
-
University of Southern DenmarkSpine Centre of Southern DenmarkUkendtLændesmerter | Post traumatisk stress syndrom
-
University Health Network, TorontoAfsluttet
-
Instituto Nacional de Cardiologia de LaranjeirasRekrutteringKognitiv dysfunktion | HjertesygdomBrasilien
-
Biolux Research Holdings, Inc.AfsluttetOrtodontisk tandbevægelseCanada
-
University of FloridaAfsluttetFølsomhedForenede Stater
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health...RekrutteringHuman papillomavirus infektionForenede Stater
-
Roswell Park Cancer InstituteAfsluttetFedme | Overvægtig | Anatomisk fase I brystkræft AJCC v8 | Anatomisk fase IA brystkræft AJCC v8 | Anatomisk fase IB brystkræft AJCC v8 | Anatomisk fase II brystkræft AJCC v8 | Anatomisk fase IIA brystkræft AJCC v8 | Anatomisk fase IIB brystkræft AJCC v8 | Anatomisk fase III brystkræft AJCC v8 | Anatomisk fase... og andre forholdForenede Stater
-
Mayo ClinicAktiv, ikke rekrutterende
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityAfsluttetOndartet neoplasmaForenede Stater
-
Fred Hutchinson Cancer CenterPrevent Cancer FoundationAfsluttet