Stress Reduction Training for Emotion Regulation and Well... | NCT03485807

Studies
Stress Reduction Training for Emotion Regulation and Well-Being

NCT03485807

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Feb 19, 2020Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Stress Reduction

Interventions

Mindfulness Training (MT)
Active Coping Training (CT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2018Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

Dec 20, 2019Actual

First Submitted Date

Mar 26, 2018

First Submission Date that Met QC Criteria

Mar 26, 2018

First Posted Date

Apr 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2020

Last Update Posted Date

Feb 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness Training (MT)	Experimental		Behavioral: Mindfulness Training (MT)
Active Coping Training (CT)	Experimental		Behavioral: Active Coping Training (CT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Training (MT)	Behavioral	2 week SmartPhone-based mindfulness training	Mindfulness Training (MT)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Neural activation associated with emotion regulation	Measured by functional magnetic resonance imaging (fMRI) during affective face matching task	Baseline, post-test (within 3 weeks after intervention)
Change in level of stress, desires, social conflict in daily life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kirk W Brown, PhD	Virginia Commonwealth University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34366804	Derived	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.