Mechanisms of Mindfulness-based Interventions

Completed

Conditions: Depression
Stress
Anxiety

Interventions: Behavioral: Mindfulness-based Stress Reduction (MBSR)
Behavioral: Mindfulness-based Cognitive Therapy (MBCT)

Registration Number: NCT03571386

Lead Sponsor: Vanderbilt University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Stress	Mindfulness-based Stress Reduction (MBSR)	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.
Mild to Moderate Anxiety	Mindfulness-based Cognitive Therapy (MBCT)	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.
Mild to Moderate Depression	Mindfulness-based Cognitive Therapy (MBCT)	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.

Primary Outcome Measures

Name	Time	Method
Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli	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 the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.

Secondary Outcome Measures

Name	Time	Method
Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT	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.
Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task	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.