Somatic Psychoeducational Intervention

Potential Benefits of the Somatic Psychoeducational Intervention for Improving Health and Wellness

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.

Study Overview

• Status: Completed
• Conditions: Work Related Stress
• Intervention / Treatment: Behavioral: Somatic Psychoeducational Intervention

Detailed Description

It is the intent of this proposal to experimentally explore 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 investigate whether participants who have difficulty regulation of the oxytocinergic system after listening to calming music relate to the overall functioning of the participants.
• Specific Aim 2: To investigate whether pre-intervention measures of autonomic reactivity and the neuropeptides oxytocin relate to the overall functioning of the participants
• Specific Aim 3: To determine if the intervention leads to improvements in functioning post, 1-week post, and 1-month post the Intervention
• Specific Aim 4: To identify individual characteristics that influence the effectiveness of the intervention post, 1-week post, and 1-month post intervention.

Experimental design

• The participants will be randomly assigned to either Group A or Group B. Intervention Group A will be provided the intervention in-person. Group B will be provided the intervention virtually.
• The invited participants will listen to 15-minutes of calming music via headphones pre-intervention to examine the regulation of the oxytocinergic system via providing pre and post music salivary samples. The participants will be provided the option to wear an eye mask while listening to the music to help them focus on the music.
• The invited participants will complete assessments immediately before the intervention, immediately after the intervention, 1 week after the intervention, and 1 month after the intervention. Assessments involve online measure and collection of saliva samples.
• The Somatic Psychoeducational Intervention will be provided in four classes, and the participants will be awarded for their time financially.

• Between-subject analyses will compare the session 1 data to determine if the participants in Group A exhibit greater improvements than the participants in Intervention Group B. 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 post intervention assessment, 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • The LJD Jewish Family & Community Services (JFCS) Headquarters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Somatic Psychoeducational Intervention; Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
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.	Behavioral: Somatic Psychoeducational Intervention; Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Lourdes P Dale, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Mental Health; Stress; Mindfulness; Oxytocin; Tai Chi; Burnout; Psychoeducation; Trauma; Coping Behaviors; Breathing Exercises; Polyvagal Theory; Physical Health; Emotional Health; Neuroendocrine Biomarkers; Somatic Intervention; Neuroendocrine Functioning
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: IRB202401217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No