Potential Benefits of the Somatic Psychoeducational Intervention
1 other identifier
interventional
31
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2024
CompletedNovember 10, 2025
June 1, 2024
6 months
February 15, 2023
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.
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.
Baseline up to 1-month (post-intervention)
Change in autonomic reactivity using the Body Perception Questionnaire self-report questionnaire.
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
Baseline up to 1-month (post-intervention)
Measuring Change in anxiety using the General Anxiety Disorder 7 self-report questionnaire.
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.
Baseline up to 1-month (post-intervention)
Measuring Change in social engagement using the Neuroception of Psychological Safety Scale self-report questionnaire.
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.
Baseline up to 1-month (post-intervention)
Measuring Change in Posttraumatic Stress Symptoms using the Posttraumatic Stress Disorder Checklist 5 self-report questionnaire.
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.
Baseline up to 1-month (post-intervention)
Measuring Change in Mindfulness using the Five Facets of Mindfulness self-report questionnaire.
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.
Baseline up to 1-month (post-intervention)
Measuring impact of prior adversity using the Adverse and Traumatic Experiences Scale self-report questionnaire.
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.
Baseline
Measuring change of professional health outcomes using self-report questionnaires.
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.
Baseline up to 1-month (post-intervention)
Measuring change in physical stress
This 9-item measure is scored via a 5-point Likert scale (0 = never to 4 = always). Higher sum scores represent increased physical stress
Baseline up to 1-month (post-intervention)
Measuring change in salivary oxytocin levels via Enzyme Immunoassay kit
Saliva samples were collected via a passive drool method using Thermo Scientific™ SpeciMAX™ Saliva Collection Tube (Catalog number A50696). Salivary oxytocin concentrates (pg/mL) determined via Enzyme Immunoassay kit (ELISA; Arbor Assays Catalog #K048-H1).
Baseline up to 1-month (post-intervention)
Study Arms (2)
Group A: Breath + Psychoeducation
ACTIVE COMPARATORParticipants will be asked to participate in the 3 1.5-hour intervention classes. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.
Group B: Breath + Movement + Psychoeducation
EXPERIMENTALParticipants will be asked to participate in the 3 1.5-hour intervention classes. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.
Interventions
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Related Publications (91)
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PMID: 41464305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourdes P Dale, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
March 13, 2023
Study Start
October 23, 2023
Primary Completion
April 11, 2024
Study Completion
April 11, 2024
Last Updated
November 10, 2025
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share