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Trial · Interventional

CompletedNot applicableRegistry data

Somatic Psychoeducational Intervention

NCTNCT06580119 (opens ClinicalTrials.gov in a new tab)Other idIRB202401217
Open at ClinicalTrials.govAsk about this trial

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
30 participants (actual)
Sponsor
University of Florida · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
15 Oct 2024
Primary completion
20 Feb 2025
Completion
20 Feb 2025
First posted
30 Aug 2024
Last update posted
3 Mar 2025
Conditions
Work Related Stress

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

    Somatic Psychoeducational Intervention

    NCT06580119

    15 Oct 2024 to 20 Feb 2025

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. 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 examine regulation of the oxytocinergic system * To investigate whether pre-intervention measures relate to the overall functioning * 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. * listen to 15-minutes of calming music and provide pre and post-music salivary samples * complete pre-intervention, post-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples. * participate in the intervention (which involves 4 hours; the 1-hour classes will be administered over four weeks). Researchers will compare the Intervention Group A (in-person) to Intervention Group B (virtual) to see if the Intervention Group A experiences greater improvements in their health and wellness.

Interventions

  • Somatic Psychoeducational InterventionBehavioral

Arms2

  • Experimental

    Group A: In-Person

    Participants will be asked to participate in the 4 intervention classes in person. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.

  • Active comparator

    Group B: Virtual

    Participants will be asked to participate in the 4 intervention classes virtually. 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 outcomes9

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

    Depression

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

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

    Registry description

    Anxiety

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

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

    Registry description

    Autonomic Reactivity

  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

    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

    Posttraumatic Stress Symptoms

  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

    Mindfulness

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

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

    Registry description

    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, burnout, and retention

  9. Measuring change in neuroendocrine functioning

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

    Registry description

    Oxytocin Levels

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

1 result

Feasibility study examining the short-term effects of Sonic Augmentation Technology™.

Dale et al. 2026Frontiers in psychiatry

PMID 42338740PMC13284157DOI 10.3389/fpsyt.2026.1772405PUB-42338740

CC BY1 result
Download PDFSee results (1)

More studies

1 study 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 89 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Individuals are eligible to participate if they are between 18 and 89 years old and are providers at the Jewish Family \& Community Services (JFCS) Exclusion Criteria: * Individuals are not eligible to participate if they are under 18 years old or older than 89 years old

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