Stress ReductionNCT03485807
Stress Reduction Training for Emotion Regulation and Well-Being
A study testing Mindfulness Training (MT) and Active Coping Training (CT) in people with Stress Reduction, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction
- What is being tested?
- Mindfulness Training (MT) and Active Coping Training (CT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking (will not be advertised but screened)
- 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).
- Personal SmartPhone (Android or Apple operating systems).
Who cannot join
- non-English speaking
- are unwilling or unable to complete study assessments or treatments
- present fMRI safety risks (e.g., ferromagnetic implants, body weight > 300 lbs)
- 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 ½ pack per day, alcohol intake in excess of 2 drinks per day)
- are prisoners or pregnant women
- no personal SmartPhone (Android or Apple operating systems)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: The Virginia Commonwealth University (VCU) Stress Reduction Study
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.
Read the 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
- Being tested
- Mindfulness Training (MT), Active Coping Training (CT)
- Keywords
- stress, mindfulness, active coping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training (MT)Behavioural
2 week SmartPhone-based mindfulness training
Active Coping Training (CT)Behavioural
2 week SmartPhone-based structurally equivalent coping training
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training (MT) | Experimental | Not described Receives: Behavioral: Mindfulness Training (MT) |
| Active Coping Training (CT) | Experimental | Not described Receives: Behavioral: Active Coping Training (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of lab-based emotion regulation (behavior)
Measured by affective face matching task
Measured: Baseline, post-test (within 3 weeks after intervention)
Secondary outcomes (2)
Neural activation associated with emotion regulation
Measured by functional magnetic resonance imaging (fMRI) during affective face matching task
Measured: Baseline, post-test (within 3 weeks after intervention)
Change in level of stress, desires, social conflict in daily life
Measured by ecological momentary assessments of stress, desires, social interactions
Measured: Baseline, post-test (within 3 weeks after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start23 Apr 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirk W Brown, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485807
- Sponsor's protocol ID
- HM20012124
- Status last verified
- Feb 2020
- First submitted
- 26 Mar 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34366804
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Virginia Commonwealth University (VCU) Stress Reduction Study
- ClinicalTrials.gov ID
- NCT03485807
- Acronym / sponsor ID
- HM20012124
- Conditions
- Stress Reduction
- Keywords
- stress, mindfulness, active coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training (MT) | Experimental | Behavioral: Mindfulness Training (MT) |
| Active Coping Training (CT) | Experimental | Behavioral: Active Coping Training (CT) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English speaking (will not be advertised but screened)
- 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).
- Personal SmartPhone (Android or Apple operating systems).
Key exclusion criteria (8 listed)
- non-English speaking
- are unwilling or unable to complete study assessments or treatments
- present fMRI safety risks (e.g., ferromagnetic implants, body weight > 300 lbs)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Training (MT)2 week SmartPhone-based mindfulness training | Behavioural | Mindfulness Training (MT) |
| Active Coping Training (CT)2 week SmartPhone-based structurally equivalent coping training | Behavioural | Active Coping Training (CT) |
Primary outcome
Level of lab-based emotion regulation (behavior)
Time frame: Baseline, post-test (within 3 weeks after intervention)
Measured by affective face matching task
2 secondary outcomes
Neural activation associated with emotion regulation
Time frame: Baseline, post-test (within 3 weeks after intervention)
Change in level of stress, desires, social conflict in daily life
Time frame: Baseline, post-test (within 3 weeks after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 34366804Rahrig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk W Brown, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training (MT) and Active Coping Training (CT) in people with Stress Reduction, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of lab-based emotion regulation (behavior) (time frame: Baseline, post-test (within 3 weeks after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.