Skip to main content
OpenTrials
Completed

NCT Number: NCT04190030

Virginia Commonwealth University Stress Reduction Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness Training

Behavioral

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

Cognitive Reappraisal Training

Behavioral

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

Primary outcomes

  1. 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

  1. Change in anger response

    Time frame: Baseline and 16 weeks

    The Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anger and more emotion downregulation. Higher scores would indicate more anger and less emotion downregulation.

  2. Change in disgust response

    Time frame: Baseline and 16 weeks

    The Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less disgust and more emotion downregulation. Higher scores would indicate more disgust and less emotion downregulation.

  3. Change in fear response

    Time frame: Baseline and 16 weeks

    The Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less fear and more emotion downregulation. Higher scores would indicate more fear and less emotion downregulation.

  4. Change in anxiety response

    Time frame: Baseline and 16 weeks

    The Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anxiety and more emotion downregulation. Higher scores would indicate more anxiety and less emotion downregulation.

  5. Change in sadness response

    Time frame: Baseline and 16 weeks

    The Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less sadness and more emotion downregulation. Higher scores would indicate more sadness and less emotion downregulation.

  6. Change in intergroup attitudes

    Time frame: Baseline and 16 weeks

    The Beliefs about Groups survey will be used to assess explicit intergroup attitudes. Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes.

  7. Behavioral willingness to participate in a dyad-based future experiment

    Time frame: 16 weeks

    Number of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Mind & Life Foundation

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.