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Stress Reduction Training for Emotion Regulation and Well-Being

The Virginia Commonwealth University (VCU) Stress Reduction Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03485807
Enrollment
21
Registered
2018-04-02
Start date
2018-04-23
Completion date
2019-12-20
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Reduction

Keywords

stress, mindfulness, active coping

Brief summary

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.

Detailed description

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.

Interventions

2 week SmartPhone-based mindfulness training

BEHAVIORALActive Coping Training (CT)

2 week SmartPhone-based structurally equivalent coping training

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. English speaking (will not be advertised but screened) 2. Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened) 3. Free of major, uncorrected sensory impairments and cognitive deficits 4. 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). 5. Personal SmartPhone (Android or Apple operating systems).

Exclusion criteria

1. non-English speaking 2. are unwilling or unable to complete study assessments or treatments 3. present fMRI safety risks (e.g., ferromagnetic implants, body weight \> 300 lbs) 4. report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months 5. report a hospitalization over the last 3 months 6. 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) 7. are prisoners or pregnant women 8. no personal SmartPhone (Android or Apple operating systems)

Design outcomes

Primary

MeasureTime frameDescription
Level of lab-based emotion regulation (behavior)Baseline, post-test (within 3 weeks after intervention)Measured by affective face matching task

Secondary

MeasureTime frameDescription
Neural activation associated with emotion regulationBaseline, post-test (within 3 weeks after intervention)Measured by functional magnetic resonance imaging (fMRI) during affective face matching task
Change in level of stress, desires, social conflict in daily lifeBaseline, post-test (within 3 weeks after intervention)Measured by ecological momentary assessments of stress, desires, social interactions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026