Stress Reduction Training for Emotion Regulation and Well-Being

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03485807
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Reduction	Behavioral: Mindfulness Training (MT); Behavioral: Active Coping Training (CT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: The Virginia Commonwealth University (VCU) Stress Reduction Study
• Actual Study Start Date: Apr 23, 2018
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Training (MT)	Behavioral: Mindfulness Training (MT); 2 week SmartPhone-based mindfulness training
Experimental: Active Coping Training (CT)	Behavioral: Active Coping Training (CT); 2 week SmartPhone-based structurally equivalent coping training

Outcome Measures

Primary Outcome Measures

1. Level of lab-based emotion regulation (behavior) [Baseline, post-test (within 3 weeks after intervention)]

   Measured by affective face matching task

Secondary Outcome Measures

1. Neural activation associated with emotion regulation [Baseline, post-test (within 3 weeks after intervention)]

   Measured by functional magnetic resonance imaging (fMRI) during affective face matching task

2. Change in level of stress, desires, social conflict in daily life [Baseline, post-test (within 3 weeks after intervention)]

   Measured by ecological momentary assessments of stress, desires, social interactions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Kirk W Brown, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

• Informed Consent Form - Sep 9, 2019

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03485807
• Other Study ID Numbers: HM20012124
• First Posted: Apr 2, 2018
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Virginia Commonwealth University: stress; mindfulness; active coping

Study Results

No Results Posted as of Feb 19, 2020