Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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 names:
    • MBSR

More Details

Status
Unknown status
Sponsor
Vanderbilt University Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.