NCT03485807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

March 26, 2018

Last Update Submit

February 17, 2020

Conditions

Stress Reduction

Keywords

stressmindfulnessactive coping

Outcome Measures

Primary Outcomes (1)

  • Level of lab-based emotion regulation (behavior)

    Measured by affective face matching task

    Baseline, post-test (within 3 weeks after intervention)

Secondary Outcomes (2)

  • Neural activation associated with emotion regulation

    Baseline, post-test (within 3 weeks after intervention)

  • Change in level of stress, desires, social conflict in daily life

    Baseline, post-test (within 3 weeks after intervention)

Study Arms (2)

Mindfulness Training (MT)

EXPERIMENTAL
Behavioral: Mindfulness Training (MT)

Active Coping Training (CT)

EXPERIMENTAL
Behavioral: Active Coping Training (CT)

Interventions

Mindfulness Training (MT)BEHAVIORAL

2 week SmartPhone-based mindfulness training

Mindfulness Training (MT)
Active Coping Training (CT)BEHAVIORAL

2 week SmartPhone-based structurally equivalent coping training

Active Coping Training (CT)

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 34366804DERIVED

Study Officials

  • Kirk W Brown, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

April 23, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

US(1)