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Completed

NCT Number: NCT03571386

Mechanisms of Mindfulness-based Interventions

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MBCT

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.

Other names: MBSR

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

    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.

Secondary outcomes

  1. 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)

    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.

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

    Time frame: Baseline to ~12 weeks

    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.

Other outcomes

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

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

    The Depression & Anxiety Stress Scale (DASS-Anxiety) (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

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

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

    The Perceived Stress Scale (PSS-14) is a 14-item scale, with a total range from 0 (no symptoms) to 56 (highest severity) Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Mechanisms of Mindfulness-Based Interventions (MBIs)

Acronym: MBI

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 27, 2018
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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