N/A
N=136
Mechanisms of Mindfulness-based Interventions
Depression · Anxiety · Stress
Bottom Line
View on ClinicalTrials.gov: NCT03571386 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli — 2.315; 2.13; -2.255 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Mindfulness-based Cognitive Therapy (MBCT) (Behavioral); Mindfulness-based Stress Reduction (MBSR) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli |
2.315; 2.13; -2.255 | — |
| SECONDARY Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT |
2.62; 2.60; 2.68; 2.58; 1.19; .87 | — |
| SECONDARY Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task |
303.50; 298.30; 304.51; 301.29; 301.47; 297.5 | — |
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.
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 ( 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
Data sourced from ClinicalTrials.gov (NCT03571386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.