Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766852
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2023-02-15
Brief Title:
Potential Benefits of the Somatic Psychoeducational Intervention
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Potential Benefits of the Somatic Psychoeducational Intervention for Improving the Health and Wellness of Healthcare Providers
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Interventions
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 45 hours the 15-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 Interventions
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 45 hours the 15-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 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 15-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 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 15-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None