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Clinical Trials/NCT04190030
NCT04190030
Completed
Not Applicable

Virginia Commonwealth University Stress Reduction Study

Virginia Commonwealth University1 site in 1 country72 target enrollmentJuly 19, 2021
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Virginia Commonwealth University
Enrollment
72
Locations
1
Primary Endpoint
Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.

Detailed Description

The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.

Registry
clinicaltrials.gov
Start Date
July 19, 2021
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
  • Free of major, uncorrected sensory impairments and cognitive deficits
  • Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
  • Adults aged 18 - 55 years of age
  • Right hand dominant (will not be advertised but screened)
  • Personal SmartPhone (Android or iOS operating systems).
  • Naive to meditation practice (will not be advertised but screened)
  • At least a moderate level of perceived stress (scale score \> 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)

Exclusion Criteria

  • left-handed
  • are unwilling or unable to complete study assessments or treatments
  • report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
  • report a hospitalization over the last 3 months
  • report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day)
  • are prisoners
  • no personal SmartPhone (Android or iOS operating systems)

Outcomes

Primary Outcomes

Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change

Time Frame: Baseline and 16 weeks

Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.

Secondary Outcomes

  • Change in anger response(Baseline and 16 weeks)
  • Change in sadness response(Baseline and 16 weeks)
  • Change in disgust response(Baseline and 16 weeks)
  • Change in intergroup attitudes(Baseline and 16 weeks)
  • Change in fear response(Baseline and 16 weeks)
  • Change in anxiety response(Baseline and 16 weeks)
  • Behavioral willingness to participate in a dyad-based future experiment(16 weeks)

Study Sites (1)

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