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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05766852
• Other study ID #: IRB202200233
• Status: Completed
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Stress
• Work Related Stress

Intervention

Behavioral:
• Somatic Psychoeducational Intervention
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.

Locations

Country	Name	City	State
United States	UF Health Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)