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Virginia Commonwealth University Stress Reduction Study

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Stress

Treatments

Behavioral: mindfulness training
Behavioral: cognitive reappraisal training

Study type

Interventional

Funder types

Other

Identifiers

NCT04190030
HM20015897

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 88 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups

Mindfulness
Experimental group
Treatment:
Behavioral: mindfulness training
Cognitive reappraisal
Active Comparator group
Treatment:
Behavioral: cognitive reappraisal training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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