Mechanisms of Mindfulness-based Interventions

NCT03571386 | Completed Results

• 1 other identifier: Osher_Center_CNIM Lab
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Stress

Keywords

Mindfulness; Depression; Anxiety; stress

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline to 12 weeks (pre- to post-MBCT)

• Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task

  Baseline to ~12 weeks

Other Outcomes (2)

• Self-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness Training

  Baseline to ~12 weeks pre- to post-MBCT (depression/anxiety cohort)

• Self-report Psychological Measures of Stress Pre- to Post-Mindfulness Training

  Baseline to ~12 weeks pre- to post-MBSR (high stress cohort)

Study Arms (2)

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.

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.

Behavioral: Mindfulness-based Stress Reduction (MBSR)

Interventions

Mindfulness-based Cognitive Therapy (MBCT) BEHAVIORAL

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

Also known as: MBCT

Mild to Moderate Depression and/or Anxiety

Mindfulness-based Stress Reduction (MBSR) BEHAVIORAL

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.

Also known as: MBSR

High Stress

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• 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.

  PMID: 31605728 BACKGROUND

• 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.

  PMID: 30682701 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33156156 BACKGROUND

• 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.

  PMID: 35668874 RESULT

• 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.

  PMID: 34732969 RESULT

Biospecimen

Retention: NONE RETAINED

Whole blood assays (WBA) will be used in conjunction with lipopolysaccharide (LPS)-stimulated whole blood cell cultures for detecting reliable cytokine responsivity. Introducing LPS as an in vitro stimulus to study the potential variable effect on cytokines such as TNFα gene expression in fresh whole blood as compared to fresh PBMCs or frozen PBMCs has demonstrated to be successful and with less variability than peripheral markers. The WBA uses a small sample volume (approximately 1-2 ml).

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Mindfulness-Based Cognitive Therapy; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: David Vago
• Organization: Vanderbilt University

vago.dave@gmail.com

236-516-6530

Study Officials

• David R Vago, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Poppy Schoenberg, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Resh Gupta, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director; Associate Professor

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: January 8, 2019
• Primary Completion: July 2, 2021
• Study Completion: September 30, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)