DepressionMBINCT03571386

Mechanisms of Mindfulness-based Interventions

An observational study of Depression and Anxiety, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Depression, Anxiety, Stress
What is being tested?: Mindfulness-based Cognitive Therapy (MBCT) and Mindfulness-based Stress Reduction (MBSR)
Type of treatment: Lifestyle or therapy programme
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 8 Jan 2019to 30 Sep 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 55 years
All sexes
No healthy volunteers
Adult

Study population: Mindfulness-Based Cognitive Therapy or Mindfulness-based Stress Reduction program participants in an integrative health clinic

Across all ARMS:

At prescreen, must be currently registered for MBCT or MBSR; at posttest, must have attended five of eight sessions for "completion".
Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions
Age range: 18-55
Right-handed
If currently taking maintenance anti-depressant and/or anti-anxiety medication, must have a "stable" regimen as indexed by no medication or dosage changes within the past three months
No prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder
No current history (< 6 months) of substance abuse/dependence
No current history (< 6 months) of regular meditation practice (>1 session/week; >10 min/session)
No history of medical illness associated with possible changes in cerebral tissue or cerebrovasculature or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes)
No current suicidal ideation

Eligibility for Depression \& Anxiety Cohort:

Depression

Reports having been diagnosed with non-psychotic unipolar major depressive disorder (MDD)
≥3 previous episodes of MDD
Beck Depression Inventory-II (BDI-II) score between 14 and 28 (an indicator of depressive symptoms of mild to moderate severity)
No fMRI contraindications: pregnancy, claustrophobia, or presence of a ferromagnetic object, including orthodontic braces

Anxiety:

Reports having been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, panic disorder, specific phobia)
Score of ≥40 on the Trait subscale of the Spielberger State-Trait Anxiety Inventory (an indicator of anxious symptoms of moderate to high severity)

Eligibility for High Stress Cohort:

Reports of High Stress as measured by perceived Stress Scale

Eligibility for Drawing Blood:

At least 110 pounds
Not pregnant
Generally healthy by self-report (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no symptoms of a heart condition within six months prior to collection, no known sickle cell disease)
Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL
No more than one blood draw will have occurred during the preceding week

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Mechanisms of Mindfulness-Based Interventions (MBIs)

Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes.

Read the detailed description

The state of mindfulness can be described as a form of meta-awareness in which attention is allocated to the present moment of external and internal sensory or mental experience, without reactivity, and without dwelling on any particular sensory or mental object with judgement or evaluation. Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes.

MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. Empirically supported MBIs include acceptance and commitment therapy (ACT; Hayes, Strosahl, \& Wilson, 1999), dialectical behavior therapy (DBT; Linehan, 1993), mindfulness-based cognitive therapy (MBCT; Segal, Williams, \& Teasdale, 2002), and mindfulness-based stress reduction (MBSR; Kabat-Zinn, 1982, 1990). Variations on these approaches, including integration of mindfulness training into individual psychotherapy from diverse perspectives, also have been described (Germer, Siegel, \& Fulton, 2005). As the empirical evidence for the efficacy of these interventions continues to grow, the importance of investigating the mechanisms or processes by which they lead to beneficial outcomes is increasingly recognized. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes. Target (mechanism) engagement is expected to facilitate identification of individuals who are most likely to benefit (or not) from MBIs and further develop targeted interventions for optimization of delivery. Although there are very specific aims and hypotheses to be tested, this preliminary exploratory investigation will provide feasibility data and allow for refining existing hypotheses for larger research proposals to be submitted for extramural grant support.

Conditions: Depression, Anxiety, Stress
Being tested: Mindfulness-based Cognitive Therapy (MBCT), Mindfulness-based Stress Reduction (MBSR)
Keywords: Mindfulness, Depression, Anxiety, stress
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Cognitive Therapy (MBCT)Behavioural
Also called MBCT
Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed
Mindfulness-based Stress Reduction (MBSR)Behavioural
Also called MBSR
Standardized 8-week patient-centered educational approach which uses relatively intensive training in core meditation practices that teaches people how to take better care of themselves using mindfulness skills and live healthier and more adaptive lives.

Study groups in NCT03571386
Study group	Role	What they receive
Mild to Moderate Depression and/or Anxiety		Patients who currently have mild to moderate severity of depression and/or anxiety symptoms are who are receiving Mindfulness-Based Cognitive Therapy (MBCT) in a group setting as standard of care will be recruited for this arm. Receives: Behavioral: Mindfulness-based Cognitive Therapy (MBCT)
High Stress		Patients with a history of reported stress who are receiving Mindfulness-Based Stress Reduction (MBSR) in a group setting as standard of care will be recruited for this study. All patients are eligible. Receives: Behavioral: Mindfulness-based Stress Reduction (MBSR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli
fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.
Measured: Baseline to 12 weeks

Secondary outcomes (2)

Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT
P1 Evoked event-related electrical potentials (ERP) amplitudes elicited from specific emotional threat vs. neutral stimuli were primary outcome. An 80-150 ms search window at EEG electrode P8 was used to identify the P1 peak, \& mean value around peaks (50 ms) was exported for analysis. Mean P1-Cue amplitudes were analyzed pre- to post-MBCT to determine the effects of time (pre to post-MBCT), emotion (angry vs. happy), and congruency (congruent vs. incongruent). Mean P1-Cue amplitudes in microvolts and SD for each condition are summarized below.
Measured: Baseline to 12 weeks (pre- to post-MBCT)
Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task
Effects of time (pre-MBCT versus post-MBCT), emotion (angry versus happy), and congruency (congruent probes versus incongruent probes) on reaction time (RT) was measured in mild to moderate depression/anxiety group.
Measured: Baseline to ~12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201930 Sep 2022

First posted27 Jun 2018
Study start8 Jan 2019
Primary completion2 Jul 2021
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03571386
Sponsor's protocol ID: Osher_Center_CNIM Lab
Acronym: MBI
Status last verified: Jan 2025
First submitted: 18 Jun 2018
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gupta RS, Kujawa A, Vago DR. The neural chronometry of threat-related attentional bias: Event-related potential (ERP) evidence for early and late stages of selective attentional processing. Int J Psychophysiol. 2019 Dec;146:20-42. doi: 10.1016/j.ijpsycho.2019.08.006. Epub 2019 Oct 9.
PubMed 31605728
Vago DR, Gupta RS, Lazar SW. Measuring cognitive outcomes in mindfulness-based intervention research: a reflection on confounding factors and methodological limitations. Curr Opin Psychol. 2019 Aug;28:143-150. doi: 10.1016/j.copsyc.2018.12.015. Epub 2018 Dec 27.
PubMed 30682701
Vago, D. R. (2022). How meditation changes the brain: A neurophilosophical and pragmatic account. Routledge Handbook on the Philosophy of Meditation. R. Repetti. London, Routledge.
Schuman-Olivier Z, Trombka M, Lovas DA, Brewer JA, Vago DR, Gawande R, Dunne JP, Lazar SW, Loucks EB, Fulwiler C. Mindfulness and Behavior Change. Harv Rev Psychiatry. 2020 Nov/Dec;28(6):371-394. doi: 10.1097/HRP.0000000000000277.
PubMed 33156156
Gupta RS, Kujawa A, Fresco DM, Kang H, Vago DR. Mindfulness-Based Cognitive Therapy: A Preliminary Examination of the (Event-Related) Potential for Modifying Threat-Related Attentional Bias in Anxiety. Mindfulness (N Y). 2022;13(7):1719-1732. doi: 10.1007/s12671-022-01910-x. Epub 2022 Jun 1.
PubMed 35668874
Gupta RS, Kujawa A, Vago DR. A Preliminary Investigation of ERP Components of Attentional Bias in Anxious Adults using Temporospatial Principal Component Analysis. J Psychophysiol. 2021 Oct;35(4):223-236. doi: 10.1027/0269-8803/a000275. Epub 2021 Feb 23.
PubMed 34732969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Mindfulness-Based Interventions (MBIs)
ClinicalTrials.gov ID: NCT03571386
Acronym / sponsor ID: MBI / Osher_Center_CNIM Lab
Conditions: Depression, Anxiety, Stress
Keywords: Mindfulness, Depression, Anxiety, stress
Study type: Observational
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 8 Jan 2019 (actual)
Primary completion: 2 Jul 2021 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 27 Jun 2018 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Mild to Moderate Depression and/or Anxiety	–	Behavioral: Mindfulness-based Cognitive Therapy (MBCT)Patients who currently have mild to moderate severity of depression and/or anxiety symptoms are who are receiving Mindfulness-Based Cognitive Therapy (MBCT) in a group setting as standard of care will be recruited for this arm.
High Stress	–	Behavioral: Mindfulness-based Stress Reduction (MBSR)Patients with a history of reported stress who are receiving Mindfulness-Based Stress Reduction (MBSR) in a group setting as standard of care will be recruited for this study. All patients are eligible.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Mindfulness-Based Cognitive Therapy or Mindfulness-based Stress Reduction program participants in an integrative health clinic

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-based Cognitive Therapy (MBCT)Also: MBCTStandardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed	Behavioural	Mild to Moderate Depression and/or Anxiety
Mindfulness-based Stress Reduction (MBSR)Also: MBSRStandardized 8-week patient-centered educational approach which uses relatively intensive training in core meditation practices that teaches people how to take better care of themselves using mindfulness skills and live healthier and more adaptive lives.	Behavioural	High Stress

Primary outcome

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli
Time frame: Baseline to 12 weeks
fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.

2 secondary outcomes

Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT
Time frame: Baseline to 12 weeks (pre- to post-MBCT)
Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task
Time frame: Baseline to ~12 weeks

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mild to Moderate Depression and/or Anxiety	69	50
High Stress	67	62

Primary outcome: Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli

Time frame: Baseline to 12 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Mild to Moderate Depression and/or Anxiety n = 16	High Stress n = 0
BOLD - Right Frontopolar Cortex \|	2.315 (.5)	–
BOLD - Right Dorsolateral PFC \|	2.13 (.5)	–
BOLD - Left Precuneus \|	-2.255 (.5)	–

Population analysed: Only 16 participants in Mild to moderate depression and/or anxiety participated in fMRI data collection. Participants in the "High Stress" Arm/Group were not assessed using fMRI and the subgroup was smaller given financial constraints.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild to Moderate Depression and/or Anxiety	0 of 69 (0%)	0 of 69 (0%)	0 of 69
High Stress	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31605728Gupta RS, Kujawa A, Vago DR. The neural chronometry of threat-related attentional bias: Event-related potential (ERP) evidence for early and late stages of selective attentional processing. Int J Psychophysiol. 2019 Dec;146:20-42. doi: 10.1016/j.ijpsycho.2019.08.006. Epub 2019 Oct 9.
Background: PubMed 30682701Vago DR, Gupta RS, Lazar SW. Measuring cognitive outcomes in mindfulness-based intervention research: a reflection on confounding factors and methodological limitations. Curr Opin Psychol. 2019 Aug;28:143-150. doi: 10.1016/j.copsyc.2018.12.015. Epub 2018 Dec 27.
BackgroundVago, D. R. (2022). How meditation changes the brain: A neurophilosophical and pragmatic account. Routledge Handbook on the Philosophy of Meditation. R. Repetti. London, Routledge.
Background: PubMed 33156156Schuman-Olivier Z, Trombka M, Lovas DA, Brewer JA, Vago DR, Gawande R, Dunne JP, Lazar SW, Loucks EB, Fulwiler C. Mindfulness and Behavior Change. Harv Rev Psychiatry. 2020 Nov/Dec;28(6):371-394. doi: 10.1097/HRP.0000000000000277.
Results publication: PubMed 35668874Gupta RS, Kujawa A, Fresco DM, Kang H, Vago DR. Mindfulness-Based Cognitive Therapy: A Preliminary Examination of the (Event-Related) Potential for Modifying Threat-Related Attentional Bias in Anxiety. Mindfulness (N Y). 2022;13(7):1719-1732. doi: 10.1007/s12671-022-01910-x. Epub 2022 Jun 1.
Results publication: PubMed 34732969Gupta RS, Kujawa A, Vago DR. A Preliminary Investigation of ERP Components of Attentional Bias in Anxious Adults using Temporospatial Principal Component Analysis. J Psychophysiol. 2021 Oct;35(4):223-236. doi: 10.1027/0269-8803/a000275. Epub 2021 Feb 23.
Individual participant dataSharing planned: No

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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.

David R Vago, Ph.D. principal investigator

Vanderbilt University Medical Center

Poppy Schoenberg, Ph.D. principal investigator

Vanderbilt University Medical Center

Resh Gupta, Ph.D. principal investigator

University of California, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Anxiety, run by Vanderbilt University Medical Center 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?

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 31 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli (time frame: Baseline to 12 weeks). 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 NCT03571386, which also lists 6 linked publications.

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 31 Jan 2025.