NCT06778356

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2025May 2026

First Submitted

Initial submission to the registry

January 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

January 10, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

Rumination, nature exposure, respiratory sinus arrhythmia, blood pressure

Outcome Measures

Primary Outcomes (3)

  • Respiratory Sinus Arrhythmia (RSA)

    Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).

  • Blood pressure

    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.

    Participants will complete the RAT task for 19 minutes (44 trials).

Study Arms (2)

Built environment assignment

EXPERIMENTAL

Participants will complete the study session in a built environment

Other: Built environment

Natural environment

EXPERIMENTAL

Participants will complete the study session in a natural environment.

Other: Natural environment

Interventions

Participants will complete the study session at a University student center.

Built environment assignment

Participants will complete the study session in a nature trail.

Natural environment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals 18 years of age or older.

You may not qualify if:

  • Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Rumination SyndromeArrhythmia, Sinus

Interventions

Built Environment

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment DesignEnvironmentEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 16, 2025

Study Start

February 14, 2025

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations