Mechanisms of Mindfulness-based Interventions

Depression Clinical Trial

— MBI  

Official title:

Mechanisms of Mindfulness-Based Interventions (MBIs)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03571386
• Other study ID #: Osher_Center_CNIM Lab
• Status: Active, not recruiting
• Start date: January 8, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Gupta, R. S., et al. (2021).

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-report psycho-social skills	Clinical symptoms and psycho-social skills will be assessed using standardized psychometrics	3 years
Primary	functional magnetic resonance imaging (fMRI)	Brain network and region-of-interest activity supporting mechanism engagement	3 years
Secondary	Electroencephalography (EEG)	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	3 years
Secondary	Behavioral Performance	Accuracy and response time on cognitive tasks	3 years