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Completed

NCT Number: NCT06580119

Somatic Psychoeducational Intervention

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.

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Key information

Conditions

Work Related Stress Behavior Behavioral Symptoms Burnout, Psychological Mental Disorders Occupational Diseases Occupational Stress Personal Satisfaction Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress, Psychological Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The LJD Jewish Family & Community Services (JFCS) Headquarters

Jacksonville, Florida, 32256, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatic Psychoeducational Intervention

Behavioral

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

Primary outcomes

  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)

    Depression

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

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

    Anxiety

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

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

    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)

    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)

    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)

    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)

    Prior Adversity

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

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

    Professional Fulfillment, burnout, and retention

  9. Measuring change in neuroendocrine functioning

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

    Oxytocin Levels

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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