Somatic Psychoeducational Intervention

NCT06580119 | Completed

• 1 other identifier: IRB202401217
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Work Related Stress

Keywords

Polyvagal Theory; Stress; Trauma; Neuroendocrine Biomarkers; Somatic Intervention; Oxytocin; PTSD; Mental Health; Neuroendocrine Functioning; Physical Health; Emotional Health; Coping Behaviors; Mindfulness; Burnout; Tai Chi; Psychoeducation; Breathing Exercises

Outcome Measures

Primary Outcomes (9)

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

  Depression

  Baseline up to 1-month (post-intervention)

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

  Anxiety

  Baseline up to 1-month (post-intervention)

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

  Autonomic Reactivity

  Baseline up to 1-month (post-intervention)

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

  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.

  Posttraumatic Stress Symptoms

  Baseline up to 1-month (post-intervention)

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

  Mindfulness

  Baseline up to 1-month (post-intervention)

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

  Prior Adversity

  Baseline up to 1-month (post-intervention)

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

  Professional Fulfillment, burnout, and retention

  Baseline up to 1-month (post-intervention)

• Measuring change in neuroendocrine functioning

  Oxytocin Levels

  Baseline up to 1-month (post-intervention)

Study Arms (2)

Group A: In-Person

EXPERIMENTAL

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.

Behavioral: Somatic Psychoeducational Intervention

Group B: Virtual

ACTIVE COMPARATOR

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.

Behavioral: Somatic Psychoeducational Intervention

Interventions

Somatic Psychoeducational Intervention BEHAVIORAL

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

Group A: In-Person; Group B: Virtual

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals are eligible to participate if they are between 18 and 89 years old and are providers at the Jewish Family \& Community Services (JFCS)

You may not qualify if:

• Individuals are not eligible to participate if they are under 18 years old or older than 89 years old

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

The LJD Jewish Family & Community Services (JFCS) Headquarters

Jacksonville, Florida, 32256, United States

Location

Related Publications (1)

• 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.

  PMID: 41464305 DERIVED

MeSH Terms

Conditions

Occupational Stress; Wounds and Injuries; Stress Disorders, Post-Traumatic; Psychological Well-Being; Burnout, Psychological

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction

Study Officials

• Lourdes P Dale, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be assigned to Group A or Group B. Intervention Group A will be provided the in-person intervention and Group B will be provided the virtual. During Phase 1, Group A will receive the intervention and Group B will act as the control group. During Phase 2, Group B will receive the intervention.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: October 15, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)