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Mechanisms of Mindfulness-based Interventions (MBI)

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ClinicalTrials.gov Identifier: NCT03571386
Recruitment Status : Suspended (COVID-19 pandemic)
First Posted : June 27, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
David Vago, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Depression Anxiety Stress Behavioral: Mindfulness-based Cognitive Therapy (MBCT) Behavioral: Mindfulness-based Stress Reduction (MBSR)

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.

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Study Type : Observational
Estimated Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Mindfulness-Based Interventions (MBIs)
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Mild to Moderate Depression
Patients who currently have mild to moderate severity of depression 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)
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
Other Name: MBCT

Mild to Moderate Anxiety
Patients who currently have mild to moderate severity of 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)
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
Other Name: 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)
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.
Other Name: MBSR




Primary Outcome Measures :
  1. functional magnetic resonance imaging (fMRI) [ Time Frame: 3 years ]
    Brain network and region-of-interest activity supporting mechanism engagement


Secondary Outcome Measures :
  1. Electroencephalography (EEG) [ Time Frame: 3 years ]
    Evoked event-related electrical potentials elicited from specific emotional/cognitive stimuli, as well as time-frequency changes are used as biomarkers for particular mechanism engagement

  2. Behavioral Performance [ Time Frame: 3 years ]
    Accuracy and response time on cognitive tasks


Other Outcome Measures:
  1. Self-report psycho-social skills [ Time Frame: 3 years ]
    Clinical symptoms and psycho-social skills will be assessed using standardized psychometrics


Biospecimen Retention:   Samples With DNA
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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mindfulness-Based Cognitive Therapy or Mindfulness-based Stress Reduction program participants in an integrative health clinic
Criteria

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 Cohort:

  • 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

Eligibility for Anxiety Cohort:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571386


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: David R Vago, Ph.D. Vanderbilt University Medical Center
Principal Investigator: Poppy Schoenberg, Ph.D. Vanderbilt University Medical Center
Principal Investigator: Resh Gupta, M.S. Vanderbilt University
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Responsible Party: David Vago, Research Director; Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03571386    
Other Study ID Numbers: Osher_Center_CNIM Lab
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Vago, Vanderbilt University Medical Center:
Mindfulness
Depression
Anxiety
stress
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms