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Potential Benefits of the Somatic Psychoeducational Intervention

Primary Purpose

Work Related Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somatic Psychoeducational Intervention
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Work Related Stress focused on measuring Polyvagal Theory, Stress, Trauma, Neuroendocrine biomarkers, Somatic interventions, Oxytocin, Vasopressin, PTSD, Mental health, Neuroendocrine functioning, professional health, Physical health, Emotional health, Coping behaviors, Mindfulness, Burnout, Tai Chi, Psychoeducation, Breathing exercises, healthcare providers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: The data obtained during the Screening Phase will be downloaded and moved to Statistical Package for the Social Sciences (IBM SPSS) to calculate a total distress score, which is a combination of their emotional distress scores (combination of scores for measures assessing depression, anxiety, and PTSD symptoms) and physical distress scores (combination of autonomic reactivity and physical symptoms). Total distress score will be used determine the participants who are struggling the most, who are in turn, most likely to benefit from the Somatic Psychoeducational Intervention. Researchers will use the total distress scores to determine the 70 to 80 participants who will be invited to the Intervention Phase, those with the highest total distress scores will be invited to participate.

Sites / Locations

  • UF Health JacksonvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: Breath + Psychoeducation

Group B: Breath + Movement + Psychoeducation

Arm Description

Participants 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. The 1-month post-assessment only requires participants to complete a 20-25-minute online survey via Qualtrics.

Participants 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. The 1-month post-assessment only requires participants to complete a 20-25-minute online survey via Qualtrics.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
September 27, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05766852
Brief Title
Potential Benefits of the Somatic Psychoeducational Intervention
Official Title
Potential Benefits of the Somatic Psychoeducational Intervention for Improving the Health and Wellness of Healthcare Providers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 the pre-intervention and 1-week post-intervention assessments that involves 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. This information will be used to calculate total distress scores and determine who to invite to the Intervention Phase. In the Intervention Phase, the participants will be assigned to either Group A or Group B based on their provided availability. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Related Stress
Keywords
Polyvagal Theory, Stress, Trauma, Neuroendocrine biomarkers, Somatic interventions, Oxytocin, Vasopressin, PTSD, Mental health, Neuroendocrine functioning, professional health, Physical health, Emotional health, Coping behaviors, Mindfulness, Burnout, Tai Chi, Psychoeducation, Breathing exercises, healthcare providers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be assigned to Group A or Group B and either Monday or Thursday class according to their availability. Intervention Group A will be provided the intervention including breath and psychoeducation and Group B will be provided the intervention including breath, movement, and psychoeducation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Breath + Psychoeducation
Arm Type
Active Comparator
Arm Description
Participants 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. The 1-month post-assessment only requires participants to complete a 20-25-minute online survey via Qualtrics.
Arm Title
Group B: Breath + Movement + Psychoeducation
Arm Type
Experimental
Arm Description
Participants 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. The 1-month post-assessment only requires participants to complete a 20-25-minute online survey via Qualtrics.
Intervention Type
Behavioral
Intervention Name(s)
Somatic Psychoeducational Intervention
Intervention Description
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Primary Outcome Measure Information:
Title
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.
Description
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.
Time Frame
Baseline up to 1-month (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: The data obtained during the Screening Phase will be downloaded and moved to Statistical Package for the Social Sciences (IBM SPSS) to calculate a total distress score, which is a combination of their emotional distress scores (combination of scores for measures assessing depression, anxiety, and PTSD symptoms) and physical distress scores (combination of autonomic reactivity and physical symptoms). Total distress score will be used determine the participants who are struggling the most, who are in turn, most likely to benefit from the Somatic Psychoeducational Intervention. Researchers will use the total distress scores to determine the 70 to 80 participants who will be invited to the Intervention Phase, those with the highest total distress scores will be invited to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lourdes Dale, PhD
Phone
(904) 244-9889
Email
Lourdes.dale@jax.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Brabham, MSN, PhD
Phone
(904) 861-5413
Email
Deborah.Brabham@jax.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourdes P Dale, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes P Dale
Phone
904-244-8998
Email
Lourdes.dale@jax.ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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