Clinical trial NCT03571386: Mechanisms of Mindfulness-based Interventions
Official title: Mechanisms of Mindfulness-Based Interventions (MBIs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Stress
Keywords: Mindfulness
Depression
Anxiety
stress
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mindfulness-Based Cognitive Therapy or Mindfulness-based Stress Reduction program participants in an integrative health clinic

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.

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.

Eligibility 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 \& 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

Primary outcomes:
measure: Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT
timeFrame: Baseline to 12 weeks (pre- to post-MBCT)
measure: Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task
timeFrame: Baseline to ~12 weeks
Other outcomes:
measure: Self-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness Training
timeFrame: Baseline to ~12 weeks pre- to post-MBCT (depression/anxiety cohort)
measure: Self-report Psychological Measures of Stress Pre- to Post-Mindfulness Training
timeFrame: Baseline to ~12 weeks pre- to post-MBSR (high stress cohort)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David R Vago, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Poppy Schoenberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Resh Gupta, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.