Stress Reduction Training for Emotion Regulation and Well-Being

Not Applicable

Completed

• Conditions: Stress Reduction
• Interventions: Behavioral: Mindfulness Training (MT); Behavioral: Active Coping Training (CT)

• Registration Number: NCT03485807
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Study Start: 2018-04-23
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Training (MT)	Mindfulness Training (MT)	-
Active Coping Training (CT)	Active Coping Training (CT)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Neural activation associated with emotion regulation	Baseline, 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 life	Baseline, post-test (within 3 weeks after intervention)	Measured by ecological momentary assessments of stress, desires, social interactions

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States