Current partner codePEPTIDESDE
NCT05766852·Not applicable·INTERVENTIONAL

Potential Benefits of the Somatic Psychoeducational Intervention

Status

Completed

Phase

Not applicable

Enrollment

31

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full detailed description

It is the intent of this proposal to experimentally explore in health care providers (HCP) 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 understand via the screening online assessment how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and self-reported autonomic reactivity * Specific Aim 2: To investigate whether pre-intervention measures of autonomic reactivity and the neuropeptides oxytocin relate to the overall functioning of the HCPs. * Specific Aim 3: To determine if the intervention leads to improvements in functioning 1-week and 1-month post the Intervention * Specific Aim 4: To identify individual characteristics that influence the effectiveness of the intervention 1-week and 1-month post intervention. Experimental design * In the Screening Phase, we will recruit healthcare providers, starting with bedside nurses. We will make available a link to the study so that participants could complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation. * In the Intervention Phase, the participants will be assigned to either Group A or Group B based on their provided availability. Participants who are unable to attend the in-person intervention will be invited to complete the pre-recorded intervention virtually. Intervention Group A, which will be provided the intervention including breath and psychoeducation, and Group B, which will be provided the intervention including breath, movement, and psychoeducation. * The invited participants will complete assessments 1 week before starting the assessment and 1 week after the intervention that involve online measure and collection of saliva samples. * The Somatic Psychoeducational Intervention will be provided in three 1.5-hour classes and the participants will be awarded for their participation financially and through continuing education credits. * In addition, the participants will complete the online 1-month post-intervention assessment * Between-subject analyses will compare the session 1 data to determine if the participants in Group B exhibit greater improvements than the participants in Intervention Group A. 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 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.

Interventions

Treatment arms and agents.

BEHAVIORAL

Somatic Psychoeducational Intervention

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

Timeline

From registration to results.

  1. First posted

    Mar 13, 2023

  2. Study start

    Oct 23, 2023

  3. Primary completion

    Apr 11, 2024

  4. Study completion

    Apr 11, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Nov 10, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

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.

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

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

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

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

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

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.

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

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

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.

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)

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.

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

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

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.

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

Time frame · Baseline

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.

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

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

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

UF Health Jacksonville

Jacksonville, Florida, United States

Publications

Results and literature.

PMID 35034337Alleyne S, Dale L, Robertson-Blackmore E, Kishore A, Cuffe S, Fallucco E. United States of America Child and Adolescent Psychiatrists' Career Satisfaction by Career Stage. Acad Psychiatry. 2022 Aug;46(4):441-450. doi: 10.1007/s40596-021-01577-x. Epub 2022 Jan 16.PMID 18310597Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.PMID 32485487Barello S, Palamenghi L, Graffigna G. Burnout and somatic symptoms among frontline healthcare professionals at the peak of the Italian COVID-19 pandemic. Psychiatry Res. 2020 Aug;290:113129. doi: 10.1016/j.psychres.2020.113129. Epub 2020 May 27.PMID 26441508Baribeau DA, Anagnostou E. Oxytocin and vasopressin: linking pituitary neuropeptides and their receptors to social neurocircuits. Front Neurosci. 2015 Sep 24;9:335. doi: 10.3389/fnins.2015.00335. eCollection 2015.PMID 17998077Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.PMID 15750381Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.PMID 16131297Brown RP, Gerbarg PL. Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. J Altern Complement Med. 2005 Aug;11(4):711-7. doi: 10.1089/acm.2005.11.711.PMID 29193423Cabrera A, Kolacz J, Pailhez G, Bulbena-Cabre A, Bulbena A, Porges SW. Assessing body awareness and autonomic reactivity: Factor structure and psychometric properties of the Body Perception Questionnaire-Short Form (BPQ-SF). Int J Methods Psychiatr Res. 2018 Jun;27(2):e1596. doi: 10.1002/mpr.1596. Epub 2017 Nov 28.PMID 32912963Carter CS, Kenkel WM, MacLean EL, Wilson SR, Perkeybile AM, Yee JR, Ferris CF, Nazarloo HP, Porges SW, Davis JM, Connelly JJ, Kingsbury MA. Is Oxytocin "Nature's Medicine"? Pharmacol Rev. 2020 Oct;72(4):829-861. doi: 10.1124/pr.120.019398.PMID 18655893Carter CS, Grippo AJ, Pournajafi-Nazarloo H, Ruscio MG, Porges SW. Oxytocin, vasopressin and sociality. Prog Brain Res. 2008;170:331-6. doi: 10.1016/S0079-6123(08)00427-5.PMID 24050183Carter CS. Oxytocin pathways and the evolution of human behavior. Annu Rev Psychol. 2014;65:17-39. doi: 10.1146/annurev-psych-010213-115110. Epub 2013 Sep 19.PMID 17435137Carter CS, Pournajafi-Nazarloo H, Kramer KM, Ziegler TE, White-Traut R, Bello D, Schwertz D. Oxytocin: behavioral associations and potential as a salivary biomarker. Ann N Y Acad Sci. 2007 Mar;1098:312-22. doi: 10.1196/annals.1384.006.

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