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Clinical Trials/NCT05766852
NCT05766852
Completed
Not Applicable

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

University of Florida1 site in 1 country31 target enrollmentOctober 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Work Related Stress
Sponsor
University of Florida
Enrollment
31
Locations
1
Primary Endpoint
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.
Status
Completed
Last Updated
5 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2023
End Date
April 11, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

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.

Measuring change in physical stress

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

This 9-item measure is scored via a 5-point Likert scale (0 = never to 4 = always). Higher sum scores represent increased physical stress

Measuring change in salivary oxytocin levels via Enzyme Immunoassay kit

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

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).

Study Sites (1)

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