Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580119
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Somatic Psychoeducational Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Potential Benefits of the Somatic Psychoeducational Intervention for Improving Health and Wellness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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
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 post-intervention 1-week post-intervention and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples
participate in the intervention which involves 4 hours the 1-hour classes will be administered over four weeks
Researchers will compare the Intervention Group A in-person to Intervention Group B virtual to see if the Intervention Group A 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
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 post-intervention 1-week post-intervention and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples
participate in the intervention which involves 4 hours the 1-hour classes will be administered over four weeks
Researchers will compare the Intervention Group A in-person to Intervention Group B virtual to see if the Intervention Group A experiences greater improvements in their health and wellness
Detailed Description:
It is the intent of this proposal to experimentally explore 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 participants
Specific Aim 3 To determine if the intervention leads to improvements in functioning post 1-week post and 1-month post the Intervention
Specific Aim 4 To identify individual characteristics that influence the effectiveness of the intervention post 1-week post and 1-month post intervention
Experimental design
The participants will be randomly assigned to either Group A or Group B Intervention Group A will be provided the intervention in-person Group B will be provided the intervention virtually
The invited participants will complete assessments immediately before the intervention immediately after the intervention 1 week after the intervention and 1 month after the intervention Assessments involve online measure and collection of saliva samples
The Somatic Psychoeducational Intervention will be provided in four1-hour classes and the participants will be awarded for their time financially
Between-subject analyses will compare the session 1 data to determine if the participants in Group A exhibit greater improvements than the participants in Intervention Group B 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 post intervention assessment 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 participants
Specific Aim 3 To determine if the intervention leads to improvements in functioning post 1-week post and 1-month post the Intervention
Specific Aim 4 To identify individual characteristics that influence the effectiveness of the intervention post 1-week post and 1-month post intervention
Experimental design
The participants will be randomly assigned to either Group A or Group B Intervention Group A will be provided the intervention in-person Group B will be provided the intervention virtually
The invited participants will complete assessments immediately before the intervention immediately after the intervention 1 week after the intervention and 1 month after the intervention Assessments involve online measure and collection of saliva samples
The Somatic Psychoeducational Intervention will be provided in four1-hour classes and the participants will be awarded for their time financially
Between-subject analyses will compare the session 1 data to determine if the participants in Group A exhibit greater improvements than the participants in Intervention Group B 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 post intervention assessment 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None