Virginia Commonwealth University Stress Reduction Study

NCT04190030 | Completed

• 1 other identifier: HM20015897
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.

Conditions

Stress

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

• Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change

  Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.

  Baseline and 16 weeks

Secondary Outcomes (7)

• Change in anger response

  Baseline and 16 weeks

• Change in disgust response

  Baseline and 16 weeks

• Change in fear response

  Baseline and 16 weeks

• Change in anxiety response

  Baseline and 16 weeks

• Change in sadness response

  Baseline and 16 weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

Behavioral: mindfulness training

Cognitive reappraisal

ACTIVE COMPARATOR

Behavioral: cognitive reappraisal training

Interventions

mindfulness training BEHAVIORAL

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

Mindfulness

cognitive reappraisal training BEHAVIORAL

Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.

Cognitive reappraisal

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Adults aged 18 - 55 years of age
• Right hand dominant (will not be advertised but screened)
• Personal SmartPhone (Android or iOS operating systems).
• Naive to meditation practice (will not be advertised but screened)
• At least a moderate level of perceived stress (scale score \> 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)

You may not qualify if:

• left-handed
• are unwilling or unable to complete study assessments or treatments
• 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 � pack per day, alcohol intake in excess of 2 drinks per day)
• are prisoners
• no personal SmartPhone (Android or iOS operating systems)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Mind & Life Foundation: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Hadley Rahrig, M.S.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 9, 2019
• Study Start: July 19, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)