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Completed

NCT Number: NCT03485807

Stress Reduction Training for Emotion Regulation and Well-Being

This study will examine whether stress reduction training - which a growing body of research indicates has manifold benefits for behavior regulation, emotion regulation, and other salutary outcomes of relevance to this proposal - predicts lab-based and daily life-based neural and behavioral outcomes indicative of reduced stress, including emotions, desires, and reactions to adverse events such as social conflict.

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Key information

Conditions

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions, desires, and reactions to adverse events such as social conflict. The full research project will be conducted over approximately 4-6 weeks, and will consist of two data collection sessions on the Virginia Commonwealth University (VCU) campus, one before and one after a 14-day stress reduction training course conducted via mobile phone (SmartPhone). The two courses entail instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or an active coping course. Both of these courses - mindfulness training (MT) and coping training (CT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas CT emphasizes established emotion regulation techniques to reduce stress and promote well-being.

Some study details are purposely omitted at this time to preserve scientific integrity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English speaking (will not be advertised but screened)
  • 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).
  • Personal SmartPhone (Android or Apple operating systems).

Exclusion criteria

  • non-English speaking
  • are unwilling or unable to complete study assessments or treatments
  • present fMRI safety risks (e.g., ferromagnetic implants, body weight > 300 lbs)
  • 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 ½ pack per day, alcohol intake in excess of 2 drinks per day)
  • are prisoners or pregnant women
  • no personal SmartPhone (Android or Apple operating systems)

Treatment and study plan

Mindfulness Training (MT)

Behavioral

2 week SmartPhone-based mindfulness training

Active Coping Training (CT)

Behavioral

2 week SmartPhone-based structurally equivalent coping training

Primary outcomes

  1. Level of lab-based emotion regulation (behavior)

    Time frame: Baseline, post-test (within 3 weeks after intervention)

    Measured by affective face matching task

Secondary outcomes

  1. Neural activation associated with emotion regulation

    Time frame: Baseline, post-test (within 3 weeks after intervention)

    Measured by functional magnetic resonance imaging (fMRI) during affective face matching task

  2. Change in level of stress, desires, social conflict in daily life

    Time frame: Baseline, post-test (within 3 weeks after intervention)

    Measured by ecological momentary assessments of stress, desires, social interactions

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

The Virginia Commonwealth University (VCU) Stress Reduction Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2018
Registry last updated
Feb 19, 2020

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.

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