Mechanisms of Mindfulness-based Interventions

NCT ID: NCT03571386

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2022-09-30

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.

Conditions

Depression; Anxiety; Stress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Mindfulness-based Cognitive Therapy (MBCT)

Intervention Type: 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

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.

Mindfulness-based Stress Reduction (MBSR)

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBCT; MBSR

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Vago

Research Director; Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Vago, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Poppy Schoenberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Resh Gupta, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31605728 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30682701 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 33156156 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35668874 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34732969 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Osher_Center_CNIM Lab

Identifier Type: -

Identifier Source: org_study_id