RuminationRUMINCT06778356
Effect of Environment on the Central and Peripheral Nervous System
A study testing Built environment and Natural environment in people with Rumination, run by University of South Florida at 1 site in United States.
Trial summary
The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rumination
- What is being tested?
- Built environment and Natural environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals 18 years of age or older.
Who cannot join
- Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.
Read the detailed description
This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.
- Conditions
- Rumination
- Being tested
- Built environment, Natural environment
- Keywords
- Rumination, nature exposure, respiratory sinus arrhythmia, blood pressure
- Medical subject headings
- Rumination Syndrome, Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Built environmentOther
Participants will complete the study session at a University student center.
Natural environmentOther
Participants will complete the study session in a nature trail.
| Study group | Role | What they receive |
|---|---|---|
| Built environment assignment | Experimental | Participants will complete the study session in a built environment Receives: Other: Built environment |
| Natural environment | Experimental | Participants will complete the study session in a natural environment. Receives: Other: Natural environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Sinus Arrhythmia (RSA)
Measured: Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).
Blood pressure
Measured: Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).
Remote Associates Test (RAT)
In this study, the remote associates test (RAT) will be used as a challenging task to induce sympathetic arousal. Each RAT item consists of three words, participants will be asked to generate a fourth word/solution associated with the words presented by means of a compound word, synonymy, or semantic association. The participant has provided a fourth/solution word or the 30 second time limit. The task will consist of a total of 39 trials, including 5 practice trials.
Measured: Participants will complete the RAT task for 19 minutes (44 trials).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start14 Feb 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies of the same condition, open and under way.
- More trials run by University of South 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Rodriguez, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778356
- Sponsor's protocol ID
- STUDY007343
- Acronym
- RUMI
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Environment on the Central and Peripheral Nervous System
- ClinicalTrials.gov ID
- NCT06778356
- Acronym / sponsor ID
- RUMI / STUDY007343
- Conditions
- Rumination
- Keywords
- Rumination, nature exposure, respiratory sinus arrhythmia, blood pressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 16 Jan 2025 (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 main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.
Detailed description
This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Built environment assignment | Experimental | Other: Built environmentParticipants will complete the study session in a built environment |
| Natural environment | Experimental | Other: Natural environmentParticipants will complete the study session in a natural environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals 18 years of age or older.
Key exclusion criteria (1 listed)
- Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.
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 |
|---|---|---|
| Built environmentParticipants will complete the study session at a University student center. | Other | Built environment assignment |
| Natural environmentParticipants will complete the study session in a nature trail. | Other | Natural environment |
Primary outcome
Respiratory Sinus Arrhythmia (RSA)
Time frame: Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).
Blood pressure
Time frame: Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).
Remote Associates Test (RAT)
Time frame: Participants will complete the RAT task for 19 minutes (44 trials).
In this study, the remote associates test (RAT) will be used as a challenging task to induce sympathetic arousal. Each RAT item consists of three words, participants will be asked to generate a fourth word/solution associated with the words presented by means of a compound word, synonymy, or semantic association. The participant has provided a fourth/solution word or the 30 second time limit. The task will consist of a total of 39 trials, including 5 practice trials.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Built environment and Natural environment in people with Rumination, run by University of South 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: enrolling by invitation, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
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?
Respiratory Sinus Arrhythmia (RSA) (time frame: Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.