Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2024-10-15
2025-02-20
Brief Summary
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* 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 examine regulation of the oxytocinergic system
* To investigate whether pre-intervention measures relate to the overall functioning
* 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.
* listen to 15-minutes of calming music and provide pre and post-music salivary samples
* 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.
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Detailed Description
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Specific Aims:
* Specific Aim 1: To investigate whether participants who have difficulty regulation of the oxytocinergic system after listening to calming music relate to the overall functioning of the participants.
* 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 listen to 15-minutes of calming music via headphones pre-intervention to examine the regulation of the oxytocinergic system via providing pre and post music salivary samples. The participants will be provided the option to wear an eye mask while listening to the music to help them focus on the music.
* 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 four 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
During Phase 1, Group A will receive the intervention and Group B will act as the control group. During Phase 2, Group B will receive the intervention.
SUPPORTIVE_CARE
NONE
Study Groups
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Group A: In-Person
Participants will be asked to participate in the 4 intervention classes in person. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.
Somatic Psychoeducational Intervention
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
Group B: Virtual
Participants will be asked to participate in the 4 intervention classes virtually. The pre-intervention and post-intervention assessments will require participants to complete a 20-25-minute online survey via Qualtrics and provide saliva samples.
Somatic Psychoeducational Intervention
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
89 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Lourdes P Dale, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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The LJD Jewish Family & Community Services (JFCS) Headquarters
Jacksonville, Florida, United States
Countries
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Other Identifiers
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IRB202401217
Identifier Type: -
Identifier Source: org_study_id
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