Work Related StressNCT06580119
Somatic Psychoeducational Intervention
A study testing Somatic Psychoeducational Intervention in people with Work Related Stress, run by University of Florida at 1 site in United States.
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. The main goals of the study are: To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Related Stress
- What is being tested?
- Somatic Psychoeducational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals are eligible to participate if they are between 18 and 89 years old and are providers at the Jewish Family \& Community Services (JFCS)
Who cannot join
- Individuals are not eligible to participate if they are under 18 years old or older than 89 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
The LJD Jewish Family & Community Services (JFCS) Headquarters
Jacksonville, Florida, 32256
About this study
Official title: Potential Benefits of the Somatic Psychoeducational Intervention for Improving Health and Wellness
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 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.
Read more
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.
Read the 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 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
- Work Related Stress
- Being tested
- Somatic Psychoeducational Intervention
- Keywords
- Polyvagal Theory, Stress, Trauma, Neuroendocrine Biomarkers, Somatic Intervention, Oxytocin, PTSD, Mental Health, Neuroendocrine Functioning, Physical Health, Emotional Health, Coping Behaviors, Mindfulness, Burnout, Tai Chi, Psychoeducation, Breathing Exercises
- Medical subject headings
- Occupational Stress, Wounds and Injuries, Stress Disorders, Post-Traumatic, Psychological Well-Being, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic Psychoeducational InterventionBehavioural
Participants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Group A: In-Person | Experimental | 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. Receives: Behavioral: Somatic Psychoeducational Intervention |
| Group B: Virtual | Active comparator | 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. Receives: Behavioral: Somatic Psychoeducational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.
Depression
Measured: Baseline up to 1-month (post-intervention)
Measuring Change in anxiety using the General Anxiety Disorder 7 self-report questionnaire.
Anxiety
Measured: Baseline up to 1-month (post-intervention)
Measuring Change in autonomic reactivity using the Body Perception Questionnaire self-report questionnaire.
Autonomic Reactivity
Measured: Baseline up to 1-month (post-intervention)
Measuring Change in social engagement using the Neuroception of Psychological Safety Scale self-report questionnaire.
Social Engagement
Measured: Baseline up to 1-month (post-intervention)
Measuring Change in Posttraumatic Stress Symptoms using the Posttraumatic Stress Disorder Checklist 5 self-report questionnaire.
Posttraumatic Stress Symptoms
Measured: Baseline up to 1-month (post-intervention)
Measuring Change in Mindfulness using the Five Facets of Mindfulness self-report questionnaire.
Mindfulness
Measured: Baseline up to 1-month (post-intervention)
Measuring impact of prior adversity using the Adverse and Traumatic Experiences Scale self-report questionnaire.
Prior Adversity
Measured: Baseline up to 1-month (post-intervention)
Measuring change of professional health outcomes using self-report questionnaires.
Professional Fulfillment, burnout, and retention
Measured: Baseline up to 1-month (post-intervention)
Measuring change in neuroendocrine functioning
Oxytocin Levels
Measured: Baseline up to 1-month (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Oct 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Work Related StressStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be assigned to Group A or Group B. Intervention Group A will be provided the in-person intervention and Group B will be provided the virtual. 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lourdes P Dale, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580119
- Sponsor's protocol ID
- IRB202401217
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dale LP, Dana AN, Lee CE, Lamont H, Van Vleet Goelz D, Dale CV, Nazarloo P, McIntosh M, Cuffe SP. Feasibility study examining the short-term effects of Sonic Augmentation Technology. Front Psychiatry. 2026 Jun 8;17:1772405. doi: 10.3389/fpsyt.2026.1772405. eCollection 2026.
PubMed 42338740Dale LP, Dana AN, Lamont H, Nazarloo P, Carter CS, Porges SW, Cuffe SP, Van Vleet Goelz D. Somatic Psychoeducational Intervention Is Associated with Increased Oxytocin Levels, Improved Autonomic Function, and Reduced Psychological Distress Symptoms in Medical and Social Care Professionals. Healthcare (Basel). 2025 Dec 10;13(24):3236. doi: 10.3390/healthcare13243236.
PubMed 41464305
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefits of the Somatic Psychoeducational Intervention for Improving Health and Wellness
- ClinicalTrials.gov ID
- NCT06580119
- Acronym / sponsor ID
- IRB202401217
- Conditions
- Work Related Stress
- Keywords
- Polyvagal Theory, Stress, Trauma, Neuroendocrine Biomarkers, Somatic Intervention, Oxytocin, PTSD, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be assigned to Group A or Group B. Intervention Group A will be provided the in-person intervention and Group B will be provided the virtual. 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: In-Person | Experimental | Behavioral: Somatic Psychoeducational InterventionParticipants 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. |
| Group B: Virtual | Active comparator | Behavioral: Somatic Psychoeducational InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals are eligible to participate if they are between 18 and 89 years old and are providers at the Jewish Family \& Community Services (JFCS)
Key exclusion criteria (1 listed)
- Individuals are not eligible to participate if they are under 18 years old or older than 89 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic Psychoeducational InterventionParticipants will work on increasing bodily awareness by learning psychoeducation, movement techniques, and relaxation. | Behavioural | Group A: In-Person, Group B: Virtual |
Primary outcome
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Depression
Measuring Change in anxiety using the General Anxiety Disorder 7 self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Anxiety
Measuring Change in autonomic reactivity using the Body Perception Questionnaire self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Autonomic Reactivity
Measuring Change in social engagement using the Neuroception of Psychological Safety Scale self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Social Engagement
Measuring Change in Posttraumatic Stress Symptoms using the Posttraumatic Stress Disorder Checklist 5 self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Posttraumatic Stress Symptoms
Measuring Change in Mindfulness using the Five Facets of Mindfulness self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Mindfulness
Measuring impact of prior adversity using the Adverse and Traumatic Experiences Scale self-report questionnaire.
Time frame: Baseline up to 1-month (post-intervention)
Prior Adversity
Measuring change of professional health outcomes using self-report questionnaires.
Time frame: Baseline up to 1-month (post-intervention)
Professional Fulfillment, burnout, and retention
Measuring change in neuroendocrine functioning
Time frame: Baseline up to 1-month (post-intervention)
Oxytocin Levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Derived from this study: PubMed 42338740Dale LP, Dana AN, Lee CE, Lamont H, Van Vleet Goelz D, Dale CV, Nazarloo P, McIntosh M, Cuffe SP. Feasibility study examining the short-term effects of Sonic Augmentation Technology. Front Psychiatry. 2026 Jun 8;17:1772405. doi: 10.3389/fpsyt.2026.1772405. eCollection 2026.
- Derived from this study: PubMed 41464305Dale LP, Dana AN, Lamont H, Nazarloo P, Carter CS, Porges SW, Cuffe SP, Van Vleet Goelz D. Somatic Psychoeducational Intervention Is Associated with Increased Oxytocin Levels, Improved Autonomic Function, and Reduced Psychological Distress Symptoms in Medical and Social Care Professionals. Healthcare (Basel). 2025 Dec 10;13(24):3236. doi: 10.3390/healthcare13243236.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes P Dale, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatic Psychoeducational Intervention in people with Work Related Stress, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Change in Depressive Symptoms using the Patient Health Questionnaire (PHQ-8) self-report questionnaire. (time frame: Baseline up to 1-month (post-intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.