Stress Reduction Training for Emotion Regulation and Well-Being

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Stress Reduction

Treatments: Behavioral: Mindfulness Training (MT); Behavioral: Active Coping Training (CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03485807

HM20012124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Mindfulness Training (MT)

Experimental group

Treatment:

Behavioral: Mindfulness Training (MT)

Active Coping Training (CT)

Experimental group

Treatment:

Behavioral: Active Coping Training (CT)