CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 323 enrolled
Drug / intervention
Psychological Stress Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03636490
NCT03636490N/ACompleted

Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure

Columbia University·interventional·Posted Aug 17, 2018·Updated May 11, 2025

In Brief

A clinical study evaluating Psychological Stress Intervention for Blood Pressure and Psychological Stress. Completed, enrolled 323 participants across 1 site.

Detailed Summary

The study will examine urinary sodium excretion induced by psychological stress and its diurnal pattern as a novel biological mechanism that may underlie an abnormal diurnal pattern of blood pressure. The study will test the hypotheses that lower stress-induced sodium excretion is associated with an abnormal diurnal pattern of sodium excretion, and that an abnormal diurnal pattern of sodium excretion is associated with an abnormal diurnal pattern of blood pressure. Primary Aim 1: To examine the association between urinary sodium excretion after provoked psychological stress and the diurnal pattern of sodium excretion. Primary Aim 2: To examine the association between the diurnal pattern of sodium excretion and the diurnal pattern of BP. Secondary Aim: To examine whether the association between urinary sodium excretion after provoked stress and the diurnal pattern of sodium excretion is modified by ecological momentary levels of perceived stress, experienced during the daytime period. Exploratory Aim: To determine the socio-demographic, behavioral, and psychological traits, chronic stress, and biological stress-related factors that are associated with lower stress-induced sodium excretion. Identification of these factors will help determine who is at risk for having a differential sodium excretion response to psychological stress.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartNov 16, 2018
Primary CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.9 years ago

Interventions

Psychological Stress Interventionbehavioral

All enrolled participants who attended the laboratory visit underwent stress-inducing tasks (psychological stress) using validated research tools. Participants performed a 5-minute computer Stroop Color Test and a 5-minute verbal Mental Arithmetic Task. The research assistant asked the participant to work as quickly and accurately as possible for both tasks.