AzTrials
AzTrials

Work Related StressNCT05766852

Potential Benefits of the Somatic Psychoeducational Intervention

A study testing Somatic Psychoeducational Intervention in people with Work Related Stress, run by University of Florida 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
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Work Related Stress
What is being tested?
Somatic Psychoeducational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
23 Oct 2023to 11 Apr 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Potential Benefits of the Somatic Psychoeducational Intervention for Improving the Health and Wellness of Healthcare Providers

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.
Read more

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.

Read the detailed description

It is the intent of this proposal to experimentally explore in health care providers (HCP) the possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can influence emotional and physical health and autonomic and neuroendocrine functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity and non-invasive measurements of levels of oxytocin.

Specific Aims:

  • Specific Aim 1: To understand via the screening online assessment how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and self-reported autonomic reactivity
  • Specific Aim 2: To investigate whether pre-intervention measures of autonomic reactivity and the neuropeptides oxytocin relate to the overall functioning of the HCPs.
  • Specific Aim 3: To determine if the intervention leads to improvements in functioning 1-week and 1-month post the Intervention
  • Specific Aim 4: To identify individual characteristics that influence the effectiveness of the intervention 1-week and 1-month post intervention.

Experimental design

  • In the Screening Phase, we will recruit healthcare providers, starting with bedside nurses. We will make available a link to the study so that participants could complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation.
  • In the Intervention Phase, the participants will be assigned to either Group A or Group B based on their provided availability. Participants who are unable to attend the in-person intervention will be invited to complete the pre-recorded intervention virtually. Intervention Group A, which will be provided the intervention including breath and psychoeducation, and Group B, which will be provided the intervention including breath, movement, and psychoeducation.
  • The invited participants will complete assessments 1 week before starting the assessment and 1 week after the intervention that involve online measure and collection of saliva samples.
  • The Somatic Psychoeducational Intervention will be provided in three 1.5-hour classes and the participants will be awarded for their participation financially and through continuing education credits.
  • In addition, the participants will complete the online 1-month post-intervention assessment
  • Between-subject analyses will compare the session 1 data to determine if the participants in Group B exhibit greater improvements than the participants in Intervention Group A. Within-subject repeated measures analyses will determine the potential benefits of the intervention for all participants by comparing their functioning at the various time points.
  • For the outcome measures, change scores will be calculated to determine the change from the pre-intervention to the 1-week post-intervention assessment, and from the 1-week post-intervention assessment to the 1-month post-intervention assessment. These changes scores will be used to determine if there are pre-intervention factors that impact the success of the intervention.
Being tested
Somatic Psychoeducational Intervention
Keywords
Polyvagal Theory, Stress, Trauma, Neuroendocrine biomarkers, Somatic interventions, Oxytocin, Vasopressin, PTSD, Mental health, Neuroendocrine functioning, professional health, Physical health, Emotional health, Coping behaviors, Mindfulness, Burnout, Tai Chi, Psychoeducation, Breathing exercises, healthcare providers
Medical subject headings
Occupational Stress, Wounds and Injuries, Diabetes Insipidus, Stress Disorders, Post-Traumatic, Psychological Well-Being, Burnout, Psychological

What participants receive

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

  • Somatic Psychoeducational InterventionBehavioural

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

Study groups in NCT05766852
Study groupRoleWhat they receive
Group A: Breath + PsychoeducationActive comparatorParticipants 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.
Receives: Behavioral: Somatic Psychoeducational Intervention
Group B: Breath + Movement + PsychoeducationExperimentalParticipants 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.
Receives: Behavioral: Somatic Psychoeducational Intervention

What is being measured

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

  1. 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.

    Measured: Baseline up to 1-month (post-intervention)

  2. 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

    Measured: Baseline up to 1-month (post-intervention)

  3. 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.

    Measured: Baseline up to 1-month (post-intervention)

  4. 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.

    Measured: Baseline up to 1-month (post-intervention)

  5. 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.

    Measured: Baseline up to 1-month (post-intervention)

  6. 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.

    Measured: Baseline up to 1-month (post-intervention)

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: Baseline up to 1-month (post-intervention)

  9. 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

    Measured: Baseline up to 1-month (post-intervention)

  10. 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).

    Measured: Baseline up to 1-month (post-intervention)

Timeline

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

  1. First posted13 Mar 2023
  2. Study start23 Oct 2023
  3. Primary completion11 Apr 2024
  4. Study completion11 Apr 2024

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
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05766852
Sponsor's protocol ID
IRB202200233
Status last verified
Jun 2024
First submitted
15 Feb 2023
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35034337

  • 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.

    PubMed 18310597

  • 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.

    PubMed 32485487

  • 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.

    PubMed 26441508

  • 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.

    PubMed 17998077

  • 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.

    PubMed 15750381

  • 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.

    PubMed 16131297

  • 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.

    PubMed 29193423

  • 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.

    PubMed 32912963

  • 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.

    PubMed 18655893

  • 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.

    PubMed 24050183

  • 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.

    PubMed 17435137

  • 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.

    PubMed 16250744

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Somatic Psychoeducational Intervention in people with Work Related Stress, run by University of Florida 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 1 inclusion and 0 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 10 Nov 2025. 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?

Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire. (time frame: Baseline up to 1-month (post-intervention)). The study lists 10 primary outcomes in all. 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 NCT05766852, which also lists 91 linked publications.

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 10 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in