Potential Benefits of the Somatic Psychoeducational Intervention
NCT ID: NCT05766852
Last Updated: 2025-11-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
31 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-23
Study Completion Date
2024-04-11
Brief Summary
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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.
* 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
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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.
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.
Conditions
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Work Related Stress
Keywords
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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
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
The participants will be assigned to Group A or Group B and either Monday or Thursday class according to their availability. Participants who are not able to attend either Monday or Thursday will have the option to complete the intervention virtually. 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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Group A: Breath + Psychoeducation
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.
Group Type
ACTIVE_COMPARATOR
Somatic Psychoeducational Intervention
Intervention Type
BEHAVIORAL
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Group B: Breath + Movement + Psychoeducation
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.
Group Type
EXPERIMENTAL
Somatic Psychoeducational Intervention
Intervention Type
BEHAVIORAL
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Interventions
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Somatic Psychoeducational Intervention
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Florida
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lourdes P Dale, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health Jacksonville
Jacksonville, Florida, United States
Site Status
Countries
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United States
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB202200233
Identifier Type: -
Identifier Source: org_study_id