Stress Reduction Training for Emotion Regulation and Well-Being

NCT ID: NCT03485807

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2019-12-20

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.

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.

Conditions

Stress Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Training (MT)

Group Type: EXPERIMENTAL

Mindfulness Training (MT)

Intervention Type: BEHAVIORAL

2 week SmartPhone-based mindfulness training

Active Coping Training (CT)

Group Type: EXPERIMENTAL

Active Coping Training (CT)

Intervention Type: BEHAVIORAL

2 week SmartPhone-based structurally equivalent coping training

Interventions

Mindfulness Training (MT)

2 week SmartPhone-based mindfulness training

Intervention Type: BEHAVIORAL

Active Coping Training (CT)

2 week SmartPhone-based structurally equivalent coping training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirk W Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34366804 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HM20012124

Identifier Type: -

Identifier Source: org_study_id