Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and Functional Magnetic Resonance Imaging (fMRI) Studies of Schizophrenia and Depression

January 8, 2019 updated by: VA Office of Research and Development

Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and fMRI Studies of Schizophrenia and Depression

The investigators will acquire simultaneous EEG and fMRI data from Veterans with depression and schizophrenia and mentally healthy Veterans to assess early sensory responses, context updating, and responses to emotional images. Understanding how rumination affects engagement with the environment is the first step towards assessing its far-reaching cognitive and emotional costs, which cut across traditional diagnostic boundaries. Understanding how mindfulness restores information processing will increase our understanding of how, and for whom, it works.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Is "the idle mind the devil's playground?" It depends on where the wandering mind goes. If it is busy reflecting on recent activity, consolidating recent material into long term memories, and envisioning the future, then these thought patterns may be highly adaptive, allowing us to learn from the past and plan for the future. But when the mind turns to the dark side and rumination takes over, these thought patterns are maladaptive. Rumination involves recursive negative thinking focused on causes and consequences rather than solutions. It cuts across diagnostic boundaries: it is both a cause and consequence of major depressive disorder (MDD) and is related to hallucinations and delusions in schizophrenia (SZ). It affects cognitive and emotional responses, yet it can be treated with mindfulness-based therapies.

Mindfulness-meditation is a type of behavioral therapy that focuses on cultivating present focused attention, is a stress-reduction intervention that targets rumination, and improves many medical and psychiatric conditions: Trait mindfulness is associated with less distress from auditory hallucinations and fewer residual depressive symptoms. It is the practice of attending to present moment experiences and allowing emotions and thoughts to come and go without judgment, thereby avoiding a downward spiral into rumination.

Compared to simple mind wandering, a brief mindfulness induction recruits an attention network including parietal and prefrontal structures while mind wandering only recruits the default mode network (DMN) Based on data from the last funding period, the investigators know that activation of the DMN affects both basic sensory and semantic processing in SZ. The investigators propose to extend this by focusing specifically on rumination and adding patients with depression. The investigators ask how rumination affects basic sensory, cognitive and emotional responses, and if mindfulness can rescue these functions, across diagnoses and the wellness spectrum.

The investigators will acquire simultaneous EEG and fMRI data from Veterans with depression and schizophrenia and mentally healthy Veterans to assess early sensory responses, context updating, and responses to emotional images. Understanding how rumination affects engagement with the environment is the first step towards assessing its far-reaching cognitive and emotional costs, which cut across traditional diagnostic boundaries. Understanding how mindfulness restores information processing will increase our understanding of how, and for whom, it works.

The investigators predict rumination inductions will prevent the brain from fully processing a spectrum of external events, and mindfulness inductions will restore these abilities. The investigators predict trait rumination and mindfulness will modulate the effects in all groups, with exaggerated effects in those with depression or schizophrenia. The outcome variables will be EEG-based event related potentials (ERPs) and fMRI, and their integration. Symptom severity, trait rumination, and trait mindfulness will be considered in the analyses.

Aim 1: Simple effects of rumination inductions on fMRI connectivity. The investigators will compare the effects of rumination and mindfulness inductions on the connectivity between DMN and rumination-sensitive brain regions. Compared to mindfulness inductions, the investigators predict rumination will increase this connectivity, with greater effects in depressed and schizophrenia patients than in healthy controls.

Aim 2: Carry-over effects of mindfulness inductions on ERPs and fMRI and their integration. The investigators predict the effects of 30-second mindfulness inductions will persist into the subsequent visual oddball task, thereby augmenting sensory, attention, and emotional ERP components and fMRI activation in sensory, cognitive and emotional networks, compared to rumination inductions. The investigators will explore the covariance between fMRI and ERP data fusion methods as they have done previously.

Aim 3: Effects of trait rumination and mindfulness. The investigators will assess the relationship between neural data and trait rumination, mindfulness, and symptom severity in all groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center, San Francisco, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed with schizophrenia and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study.

Patients who have been diagnosed with major depressive disorder and meet our research criteria of symptoms indicative of a diagnosis of major depressive disorder within their lifetime are eligible for this study.

Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.

Description

Inclusion Criteria:

(All)

  • Veterans
  • 18-65 years of age
  • Negative metal screen for MR scanning
  • Corrected to normal vision

Inclusion Criteria (patients):

  • Meet criteria for SZ or MDD as assessed using the Structured Clinical Interview for DSM (SCID), with a consensus diagnosis between trained research staff member and an attending psychiatrist or psychologist.
  • Stable medication regime for > 1 month

Exclusion Criteria:

(All)

  • Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive sequelae)
  • Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic sequelae
  • Major medical conditions (e.g., significant hypertension, diabetes not controlled by diet alone, seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
  • Substance abuse within three months of participation or any history of substance dependence
  • History of HIV risk behaviors
  • Known claustrophobia
  • Pregnancy. If the participant cannot rule out pregnancy, a pregnancy urine test will be conducted moments before scanning.
  • Uncorrected vision as assessed by the Snellen chart.

Exclusion criteria (patients only):

- Any primary Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Axis I diagnosis other than SZ or MDD

Exclusion criteria (controls only):

  • Any past or present DSM Axis I diagnosis
  • Chronic treatment with medication that affects cognitive function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with Schizophrenia
Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime.
Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, and healthy controls.
Healthy Controls
Individuals who have not met criteria for a psychiatric disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric disorder.
Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, and healthy controls.
Patients with Major Depressive Disorder
Individuals who have been previously diagnosed with major depressive disorder and meet our research criteria for symptoms indicative of major depressive disorder within their lifetime.
Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, and healthy controls.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG)
Time Frame: Day 1
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
Day 1
Magnetic Resonance Imaging (MRI)
Time Frame: Day 1
Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.
Day 1
Memory and Attention task
Time Frame: Day 1
Listening to audio instructions.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Judith M Ford, PhD, San Francisco VA Medical Center, San Francisco, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHBB-012-17S
  • CX000497 (Other Grant/Funding Number: eRA Project Reference)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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