Stress Reduction Training for Emotion Regulation and Well-Being

Stress Reduction Clinical Trial

Official title:

The Virginia Commonwealth University (VCU) Stress Reduction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485807
• Other study ID #: HM20012124
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stress Reduction

Intervention

Behavioral:
• Mindfulness Training (MT)
2 week SmartPhone-based mindfulness training
• Active Coping Training (CT)
2 week SmartPhone-based structurally equivalent coping training

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of lab-based emotion regulation (behavior)	Measured by affective face matching task	Baseline, post-test (within 3 weeks after intervention)
Secondary	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)
Secondary	Change in level of stress, desires, social conflict in daily life	Measured by ecological momentary assessments of stress, desires, social interactions	Baseline, post-test (within 3 weeks after intervention)