NCT03571386: MBI

Mechanisms of Mindfulness-based Interventions

Completed Results posted Last updated 31 January 2025

What this trial tests

trial testing Mindfulness-based Cognitive Therapy (MBCT) in Depression in 136 participants. Completed in 30 September 2022.

Timeline

8 January 2019

Primary endpoint
2 July 2021

30 September 2022

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	136
Start date	8 January 2019
Primary completion	2 July 2021
Estimated completion	30 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-based Cognitive Therapy (MBCT)
• Mindfulness-based Stress Reduction (MBSR)

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Stress — all drugs for Stress →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 55, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli Primary · Baseline to 12 weeks

fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from t

BOLD - Right Frontopolar Cortex |

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.315	± .5

BOLD - Right Dorsolateral PFC |

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.13	± .5

BOLD - Left Precuneus |

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	-2.255	± .5

Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT Secondary · Baseline to 12 weeks (pre- to post-MBCT)

P1 Evoked event-related electrical potentials (ERP) amplitudes elicited from specific emotional threat vs. neutral stimuli were primary outcome. An 80-150 ms search window at EEG electrode P8 was used to identify the P1 peak, \& mean value around peaks (50 ms) was exported for analysis. Mean P1-Cue amplitudes were analyzed pre- to post-MBCT to determine the effects of time (pre to post-MBCT), emotion (angry vs. happy), and congruency (congruent vs. incongruent). Mean P1-Cue amplitudes in microvolts and SD for each condition are summarized below.

Mean amplitude (uv) and standard deviations for Angry Cues pre-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.62	± 2.83

Mean amplitude (uv) and standard deviations for Angry Cues post-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.60	± 2.74

Mean amplitude (uv) and standard deviations for Happy Cues pre-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.68	± 2.81

Mean amplitude (uv) and standard deviations for Happy Cues post-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	2.58	± 2.73

Mean amplitude (uv) and standard deviations for Angry Congruent Cues pre-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	1.19	± 2.32

Mean amplitude (uv) and standard deviations for Angry Congruent Cues post-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	.87	± 1.97

Mean amplitude (uv) and standard deviations for Angry Incongruent Cues pre-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	1.16	± 2.30

Mean amplitude (uv) and standard deviations for Angry Incongruent Cues post-MBCT

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	.61	± 2.24

Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task Secondary · Baseline to ~12 weeks

Effects of time (pre-MBCT versus post-MBCT), emotion (angry versus happy), and congruency (congruent probes versus incongruent probes) on reaction time (RT) was measured in mild to moderate depression/anxiety group.

RT to probes congruent with angry emotional stimuli pre-MBCT | unit of measure: mean RT & SE)

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	303.50	± 1.2

RT to probes congruent with angry emotional stimuli post-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	298.30	± 1.2

RT to probes incongruent with angry emotional stimuli pre-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	304.51	± 1.3

RT to probes incongruent with angry emotional stimuli post-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	301.29	± 1.5

RT to probes congruent with happy emotional stimuli pre-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	301.47	± 1.4

RT to probes congruent with happy emotional stimuli post-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	297.5	± 1.3

RT to probes incongruent with happy emotional stimuli pre-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	304.22	± 1.2

RT to probes incongruent with happy emotional stimuli post-MBCT | unit of measure: mean RT & SE

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	301.38	± 1.1

Self-report Psychological Measures of Anxiety and Stress Pre- to Post-Mindfulness Training Secondary · Baseline to ~12 weeks pre- to post-MBCT (depression/anxiety cohort)

The Depression \& Anxiety Stress Scale (DASS-Anxiety) (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ra

DASS-D scores pre- to post-MBCT | Mean change scores, (SE)

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	7.96	± 1.41

DASS-A mean change pre- to post-MBCT | mean change, (SE)

Group	Value	95% CI
Mild to Moderate Depression and/or Anxiety	3.68	± 1.28

Self-report Psychological Measures of Stress Pre- to Post-Mindfulness Training Secondary · Baseline to ~12 weeks pre- to post-MBSR (high stress cohort)

The Perceived Stress Scale (PSS-14) is a 14-item scale, with a total range from 0 (no symptoms) to 56 (highest severity) Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance.

Group	Value	95% CI
High Stress	-7.4	± 2.3

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Preliminary Investigation of ERP Components of Attentional Bias in Anxious Adults using Temporospatial Principal Component Analysis.
   Gupta RS, Kujawa A, Vago DR. · · 2021 · cited 5× · PMID 34732969 · DOI 10.1027/0269-8803/a000275
2. Mindfulness-Based Cognitive Therapy: A Preliminary Examination of the (Event-Related) Potential for Modifying Threat-Related Attentional Bias in Anxiety.
   Gupta RS, Kujawa A, Fresco DM, Kang H, et al · · 2022 · cited 2× · PMID 35668874 · DOI 10.1007/s12671-022-01910-x