NCT05766852

Brief Summary

The goal of this clinical trial is to explore possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can improve health and wellness in health care providers (HCP). The main goals of the study are:

  • To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and autonomic reactivity (the degree participants physiologically respond).
  • To investigate whether pre-intervention measures relate to the overall functioning of the HCPs.
  • To determine the 1-week and 1-month post-intervention effects of the Intervention(s)
  • To identify individual characteristics that influence the effectiveness of the intervention at the 1-week and 1-month post-intervention assessments. Participants will:
  • complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation.
  • complete pre-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples.
  • participated in the intervention (which involves 4.5 hours; the 1.5-hour classes will be administered over three weeks). Researchers will compare the Intervention Group A to Intervention Groub B to see if the Intervention Group B experiences greater improvements in their health and wellness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
Last Updated

November 10, 2025

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

February 15, 2023

Last Update Submit

November 5, 2025

Conditions

Keywords

Polyvagal TheoryStressTraumaNeuroendocrine biomarkersSomatic interventionsOxytocinVasopressinPTSDMental healthNeuroendocrine functioningprofessional healthPhysical healthEmotional healthCoping behaviorsMindfulnessBurnoutTai ChiPsychoeducationBreathing exerciseshealthcare providers

Outcome Measures

Primary Outcomes (10)

  • Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.

    The eight-item Patient Health Questionnaire depression scale (PHQ-8) will be used to assess current depression. Depression can be defined as ongoing feelings of sadness or loss of interest in typically pleasurable activities. This measure includes 8 items that are answered via a 4-point Likert scales (0 = not at all, 1 = several days, 2 = more than half the days, and 3 - nearly every day). Total scores range from 0 to 24, with higher indicated more symptoms of depression.

    Baseline up to 1-month (post-intervention)

  • Change in autonomic reactivity using the Body Perception Questionnaire self-report questionnaire.

    This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity

    Baseline up to 1-month (post-intervention)

  • Measuring Change in anxiety using the General Anxiety Disorder 7 self-report questionnaire.

    This 7-item measure is scored on a 4-point Likert scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Items are summed, with the higher scores indicating increased symptoms of anxiety.

    Baseline up to 1-month (post-intervention)

  • Measuring Change in social engagement using the Neuroception of Psychological Safety Scale self-report questionnaire.

    This 14-item measure is scored on a 5-point Likert scale (Strongly Disagree = 1 to Strongly Agree = 5). Items are summed, with the higher scores indicating greater social engagement.

    Baseline up to 1-month (post-intervention)

  • Measuring Change in Posttraumatic Stress Symptoms using the Posttraumatic Stress Disorder Checklist 5 self-report questionnaire.

    This 8-item measure scored on a 5-point Likert scale (not at all = 0 to extremely = 4). Items are summed, with the higher scores indicating increased symptoms are depression.

    Baseline up to 1-month (post-intervention)

  • Measuring Change in Mindfulness using the Five Facets of Mindfulness self-report questionnaire.

    This 15-item measure assess mindfulness via a 5-point Likert scale (Never or very rarely true = 1 to Very often or always true = 5). Higher sum scores are representative of greater mindfulness.

    Baseline up to 1-month (post-intervention)

  • Measuring impact of prior adversity using the Adverse and Traumatic Experiences Scale self-report questionnaire.

    This 30-item measure asks about prior adversity (i.e., Childhood adversity, caregiver maltreatment, non-caregiver maltreatment, life-threatening situations, and sudden losses). Participants indicate how impacted they were via a 5-point Likert scale (0 = event did not occur, 1 = occurred and no impact on my life, 2 = minimal impact on my life, 3 = some impact on my life, and 4 = big impact on my life). Higher sum scores are indicative of greater prior adversity.

    Baseline

  • Measuring change of professional health outcomes using self-report questionnaires.

    Professional fulfillment and Burnout was assessed via the 16-item Professional Fulfillment Index (Professional Fulfillment 6 items, Burnout \[Work Exhaustion 4 items and Interpersonal Disengagement 6 items\]). Participants indicate how true 6 items assessing Professional Fulfillment are via a 5-point Likert scale (0 = not at all true to 4 = completely true). Higher sum scores are indicative of greater Professional Fulfillment. Participants indicate the degree they have experienced 10 items assessing burnout are via a 5-point Likert scale (0 = not at all to 4 = extremely). Higher sum scores are indicative of increased burnout.

    Baseline up to 1-month (post-intervention)

  • Measuring change in physical stress

    This 9-item measure is scored via a 5-point Likert scale (0 = never to 4 = always). Higher sum scores represent increased physical stress

    Baseline up to 1-month (post-intervention)

  • Measuring change in salivary oxytocin levels via Enzyme Immunoassay kit

    Saliva samples were collected via a passive drool method using Thermo Scientific™ SpeciMAX™ Saliva Collection Tube (Catalog number A50696). Salivary oxytocin concentrates (pg/mL) determined via Enzyme Immunoassay kit (ELISA; Arbor Assays Catalog #K048-H1).

    Baseline up to 1-month (post-intervention)

Study Arms (2)

Group A: Breath + Psychoeducation

ACTIVE COMPARATOR

Participants will be asked to participate in the 3 1.5-hour intervention classes. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.

Behavioral: Somatic Psychoeducational Intervention

Group B: Breath + Movement + Psychoeducation

EXPERIMENTAL

Participants will be asked to participate in the 3 1.5-hour intervention classes. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.

Behavioral: Somatic Psychoeducational Intervention

Interventions

Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.

Group A: Breath + PsychoeducationGroup B: Breath + Movement + Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals are eligible to participate in Screening Phase of the study if they are at least 18 years old and are bedside nurses in units at the 8th street location or North Campus of the University of Florida Health.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Related Publications (91)

  • 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.

    PMID: 35034337BACKGROUND
  • 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.

    PMID: 18310597BACKGROUND
  • 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.

    PMID: 32485487BACKGROUND
  • 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.

    PMID: 26441508BACKGROUND
  • 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.

    PMID: 17998077BACKGROUND
  • 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.

    PMID: 15750381BACKGROUND
  • 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.

    PMID: 16131297BACKGROUND
  • 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.

    PMID: 29193423BACKGROUND
  • 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.

    PMID: 32912963BACKGROUND
  • 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.

    PMID: 18655893BACKGROUND
  • 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.

    PMID: 24050183BACKGROUND
  • 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.

    PMID: 17435137BACKGROUND
  • 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.

    PMID: 16250744BACKGROUND
  • 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.

    BACKGROUND
  • Champely, S. (2020). Basic Functions for Power Analysis. R package version 1.3-0, https://CRAN.R-project.org/package=pwr.

    BACKGROUND
  • 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.

    PMID: 24651556BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19707870BACKGROUND
  • 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.

    PMID: 34886045BACKGROUND
  • 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.

    PMID: 35693957BACKGROUND
  • Dale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29154592BACKGROUND
  • Doussard-Roosevelt JA, Porges SW. The role of neurobehavioral organization in stress responses: A polyvagal model. 1999.

    BACKGROUND
  • 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.

    PMID: 33770582BACKGROUND
  • 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.

    PMID: 22754878BACKGROUND
  • 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.

    PMID: 15229311BACKGROUND
  • Goelz DV. Tai chi and its effect on post-traumatic stress. Doctoral thesis. The Chicago School of Professional Psychology; 2015

    BACKGROUND
  • 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.

    PMID: 34290636BACKGROUND
  • 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.

    PMID: 18803491BACKGROUND
  • 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.

    PMID: 27047689BACKGROUND
  • 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.

    PMID: 20882821BACKGROUND
  • 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.

    PMID: 35949164BACKGROUND
  • 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.

    PMID: 27078186BACKGROUND
  • 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.

    PMID: 15078651BACKGROUND
  • 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.

    PMID: 28497641BACKGROUND
  • 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.

    PMID: 24134875BACKGROUND
  • 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.

    PMID: 33387746BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 21944261BACKGROUND
  • 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.

    PMID: 30777846BACKGROUND
  • 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.

    PMID: 29884281BACKGROUND
  • 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.

    PMID: 27504098BACKGROUND
  • 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.

    PMID: 16733617BACKGROUND
  • 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.

    PMID: 23040540BACKGROUND
  • 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.

    PMID: 33192715BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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

    BACKGROUND
  • Lan C. Tai chi improves natural harmony in autonomic function. N Am J Med Sci. 2012 Jun;4(6):276-7. No abstract available.

    PMID: 22754879BACKGROUND
  • 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.

    PMID: 32620092BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26095854BACKGROUND
  • 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.

    PMID: 34726457BACKGROUND
  • 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.

    PMID: 21852800BACKGROUND
  • 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.

    PMID: 26353072BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 33544405BACKGROUND
  • 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.

    PMID: 23756071BACKGROUND
  • 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.

    PMID: 22974560BACKGROUND
  • 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.

    PMID: 34293236BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23184401BACKGROUND
  • 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.

    BACKGROUND
  • Porges SW. Neuroception: A subconscious system for detecting threats and safety. Zero Three. 2004; 24(5):19-24.

    BACKGROUND
  • Porges, SW. Polyvagal Safety: Attachment, Communication, Self-Regulation. WW Norton & Company; 2021.

    BACKGROUND
  • Porges SW. Stress and parasympathetic control. Stress science: neuroendocrinology. 2010 Apr 6:306-12.2010

    BACKGROUND
  • Porges SW. Body Perception Questionnaire Short Form© 1993, 2015

    BACKGROUND
  • 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.

    PMID: 17049418BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12954445BACKGROUND
  • 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.

    PMID: 11587772BACKGROUND
  • 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.

    PMID: 29892247BACKGROUND
  • 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.

    PMID: 27137973BACKGROUND
  • 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.

    PMID: 26793046BACKGROUND
  • 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.

    PMID: 10786324BACKGROUND
  • 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.

    PMID: 22109077BACKGROUND
  • 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.

    PMID: 33548348BACKGROUND
  • 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.

    PMID: 32627104BACKGROUND
  • 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.

    PMID: 28376861BACKGROUND
  • 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.

    PMID: 23225031BACKGROUND
  • 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.

    PMID: 26653297BACKGROUND
  • 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.

    PMID: 27713275BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 29196982BACKGROUND
  • 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.

    PMID: 16891578BACKGROUND
  • Van der Kolk, B. Posttraumatic therapy in the age of neuroscience. Psychoanalytic dialogues. 2002;12(3): 381-392.

    BACKGROUND
  • 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.

    PMID: 32419181BACKGROUND
  • 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.

    PMID: 20633489BACKGROUND
  • 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.

    PMID: 19365797BACKGROUND
  • Dale LP, Dana AN, Lamont H, Nazarloo P, Carter CS, Porges SW, Cuffe SP, Van Vleet Goelz D. Somatic Psychoeducational Intervention Is Associated with Increased Oxytocin Levels, Improved Autonomic Function, and Reduced Psychological Distress Symptoms in Medical and Social Care Professionals. Healthcare (Basel). 2025 Dec 10;13(24):3236. doi: 10.3390/healthcare13243236.

MeSH Terms

Conditions

Occupational StressWounds and InjuriesDiabetes InsipidusStress Disorders, Post-TraumaticPsychological Well-BeingBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal Satisfaction

Study Officials

  • Lourdes P Dale, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The participants will be assigned to Group A or Group B and either Monday or Thursday class according to their availability. Participants who are not able to attend either Monday or Thursday will have the option to complete the intervention virtually. Intervention Group A will be provided the intervention including breath and psychoeducation and Group B will be provided the intervention including breath, movement, and psychoeducation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 13, 2023

Study Start

October 23, 2023

Primary Completion

April 11, 2024

Study Completion

April 11, 2024

Last Updated

November 10, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations