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Trial · Interventional

CompletedNot applicableRegistry data

Potential Benefits of the Somatic Psychoeducational Intervention

This trial does not test a peptide that PepBank tracks.

  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
31 participants (actual)
Sponsor
University of Florida · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
23 Oct 2023
Primary completion
11 Apr 2024
Completion
11 Apr 2024
First posted
13 Mar 2023
Last update posted
10 Nov 2025
Conditions
Work Related Stress

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. N/A

    Potential Benefits of the Somatic Psychoeducational Intervention

    NCT05766852

    23 Oct 2023 to 11 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Somatic Psychoeducational InterventionBehavioral

Arms2

  • Active comparator

    Group A: Breath + Psychoeducation

    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.

  • Experimental

    Group B: Breath + Movement + Psychoeducation

    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.

Primary outcomes10

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

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

    Time frame · Baseline

    Registry description

    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.

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

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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.

  9. Measuring change in physical stress

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

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

  10. Measuring change in salivary oxytocin levels via Enzyme Immunoassay kit

    Time frame · Baseline up to 1-month (post-intervention)

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies16

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2021

3 results

Developmental programming of oxytocin through variation in early-life stress: Four meta-analyses and a theoretical reinterpretation.

Ellis et al. 2021Clinical psychology reviewcited by 74

PMID 33770582DOI 10.1016/j.cpr.2021.101985PUB-33770582

Full text at the publisher3 results

Indexing hint: Observational study · 2007

1 result

Oxytocin: behavioral associations and potential as a salivary biomarker.

Carter et al. 2007Annals of the New York Academy of Sciencescited by 238

PMID 17435137DOI 10.1196/annals.1384.006PUB-17435137

Full text at the publisher1 result

More studies

14 studies on this page

PubMed tag: none · 2025

Somatic Psychoeducational Intervention Is Associated with Increased Oxytocin Levels, Improved Autonomic Function, and Reduced Psychological Distress Symptoms in Medical and Social Care Professionals.

Dale et al. 2025Healthcare (Basel, Switzerland)cited by 1

PMID 41464305PMC12732401DOI 10.3390/healthcare13243236PUB-41464305

CC BY
Download PDF

PubMed tag: none · 2021

The Oxytocinergic System as a Mediator of Anti-stress and Instorative Effects Induced by Nature: The Calm and Connection Theory.

Grahn et al. 2021Frontiers in psychologycited by 21

PMID 34290636PMC8286993DOI 10.3389/fpsyg.2021.617814PUB-34290636

CC BY
Download PDF

Indexing hint: Review · 2020

Is Oxytocin "Nature's Medicine"?

Carter et al. 2020Pharmacological reviewscited by 316

PMID 32912963PMC7495339DOI 10.1124/pr.120.019398PUB-32912963

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Review · 2015

Oxytocin and vasopressin: linking pituitary neuropeptides and their receptors to social neurocircuits.

Baribeau et al. 2015Frontiers in neurosciencecited by 154

PMID 26441508PMC4585313DOI 10.3389/fnins.2015.00335PUB-26441508

CC BY
Download PDF

Indexing hint: Review · 2015

From Autism to Eating Disorders and More: The Role of Oxytocin in Neuropsychiatric Disorders.

Romano et al. 2015Frontiers in neurosciencecited by 70

PMID 26793046PMC4709851DOI 10.3389/fnins.2015.00497PUB-26793046

CC BY
Download PDF

Indexing hint: Review · 2014

Oxytocin pathways and the evolution of human behavior.

Carter et al. 2014Annual review of psychologycited by 397

PMID 24050183DOI 10.1146/annurev-psych-010213-115110PUB-24050183

Full text at the publisher
Publisher page

Indexing hint: Review · 2013

Oxytocin, stress and social behavior: neurogenetics of the human oxytocin system.

Kumsta et al. 2013Current opinion in neurobiologycited by 187

PMID 23040540DOI 10.1016/j.conb.2012.09.004PUB-23040540

Full text at the publisher
Publisher page

Indexing hint: Review · 2013

The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings.

Cochran et al. 2013Harvard review of psychiatrycited by 202

PMID 24651556PMC4120070DOI 10.1097/hrp.0b013e3182a75b7dPUB-24651556

Rights unknown
Source link

Indexing hint: Review · 2012

Balance of brain oxytocin and vasopressin: implications for anxiety, depression, and social behaviors.

Neumann et al. 2012Trends in neurosciencescited by 747

PMID 22974560DOI 10.1016/j.tins.2012.08.004PUB-22974560

Full text at the publisher
Publisher page

Indexing hint: Review · 2011

Oxytocin and vasopressin in the human brain: social neuropeptides for translational medicine.

Meyer-Lindenberg et al. 2011Nature reviews. Neurosciencecited by 1,262

PMID 21852800DOI 10.1038/nrn3044PUB-21852800

Full text at the publisher
Publisher page

Indexing hint: Review · 2010

Oxytocin and Major Depressive Disorder: Experimental and Clinical Evidence for Links to Aetiology and Possible Treatment.

Slattery et al. 2010Pharmaceuticals (Basel, Switzerland)cited by 76

PMID 27713275PMC4033976DOI 10.3390/ph3030702PUB-27713275

CC BY
Download PDF

PubMed tag: none · 2009

Detection of salivary oxytocin levels in lactating women.

White-Traut et al. 2009Developmental psychobiologycited by 108

PMID 19365797PMC2767206DOI 10.1002/dev.20376PUB-19365797

Rights unknown
Source link

Indexing hint: Review · 2008

Oxytocin, vasopressin and sociality.

Carter et al. 2008Progress in brain researchcited by 261

PMID 18655893DOI 10.1016/s0079-6123(08)00427-5PUB-18655893

Full text at the publisher
Publisher page

Indexing hint: Review · 2001

The polyvagal theory: phylogenetic substrates of a social nervous system.

Porges et al. 2001International journal of psychophysiology : official journal of the International Organization of Psychophysiologycited by 753

PMID 11587772DOI 10.1016/s0167-8760(01)00162-3PUB-11587772

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: -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.

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