Virginia Commonwealth University Stress Reduction Study

Stress Clinical Trial

Official title:

Virginia Commonwealth University Stress Reduction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190030
• Other study ID #: HM20015897
• Status: Completed
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• mindfulness training
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 training
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Mind & Life Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in anger response	The Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anger and more emotion downregulation. Higher scores would indicate more anger and less emotion downregulation.	Baseline and 16 weeks
Secondary	Change in disgust response	The Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less disgust and more emotion downregulation. Higher scores would indicate more disgust and less emotion downregulation.	Baseline and 16 weeks
Secondary	Change in fear response	The Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less fear and more emotion downregulation. Higher scores would indicate more fear and less emotion downregulation.	Baseline and 16 weeks
Secondary	Change in anxiety response	The Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anxiety and more emotion downregulation. Higher scores would indicate more anxiety and less emotion downregulation.	Baseline and 16 weeks
Secondary	Change in sadness response	The Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less sadness and more emotion downregulation. Higher scores would indicate more sadness and less emotion downregulation.	Baseline and 16 weeks
Secondary	Change in intergroup attitudes	The Beliefs about Groups survey will be used to assess explicit intergroup attitudes. Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes.	Baseline and 16 weeks
Secondary	Behavioral willingness to participate in a dyad-based future experiment	Number of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate.	16 weeks