Potential Benefits of the Somatic Psychoeducational Intervention

Work Related Stress Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. 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. ;

Related Conditions & MeSH terms

• Occupational Stress
• Work Related Stress

• NCT number: NCT05766852
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: October 23, 2023
• Completion date: April 11, 2024