Clinical trial NCT04190030: Virginia Commonwealth University Stress Reduction Study
Official title: Virginia Commonwealth University Stress Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Mindfulness
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Mind & Life Foundation
First posted: 2019-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in anger response
timeFrame: Baseline and 16 weeks
measure: Change in disgust response
timeFrame: Baseline and 16 weeks
measure: Change in fear response
timeFrame: Baseline and 16 weeks
measure: Change in anxiety response
timeFrame: Baseline and 16 weeks
measure: Change in sadness response
timeFrame: Baseline and 16 weeks
measure: Change in intergroup attitudes
timeFrame: Baseline and 16 weeks
measure: Behavioral willingness to participate in a dyad-based future experiment
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Hadley Rahrig, M.S.
role: PRINCIPAL_INVESTIGATOR
References: