Clinical trial NCT03485807: Stress Reduction Training for Emotion Regulation and Well-Being
Official title: The Virginia Commonwealth University (VCU) Stress Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reduction
Keywords: stress
mindfulness
active coping
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Level of lab-based emotion regulation (behavior)
timeFrame: Baseline, post-test (within 3 weeks after intervention)
Secondary outcomes:
measure: Neural activation associated with emotion regulation
timeFrame: Baseline, post-test (within 3 weeks after intervention)
measure: Change in level of stress, desires, social conflict in daily life
timeFrame: Baseline, post-test (within 3 weeks after intervention)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kirk W Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahrig H, Bjork JM, Tirado C, Chester DS, Creswell JD, Lindsay EK, Penberthy JK, Brown KW. Punishment on Pause: Preliminary Evidence That Mindfulness Training Modifies Neural Responses in a Reactive Aggression Task. Front Behav Neurosci. 2021 Jul 23;15:689373. doi: 10.3389/fnbeh.2021.689373. eCollection 2021.