SchizophreniaNCT03758495
Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and Functional Magnetic Resonance Imaging (fMRI) Studies of Schizophrenia and Depression
An observational study of Schizophrenia and Depressive Disorder, Major, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Depressive Disorder, Major
- What is being tested?
- Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 2 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (All)
- Veterans
- 18-65 years of age
- Negative metal screen for MR scanning
- Corrected to normal vision
- 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
Who cannot join
- (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
Show all 12Show fewer
- 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.
- Any primary Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Axis I diagnosis other than SZ or MDD
- Any past or present DSM Axis I diagnosis
- Chronic treatment with medication that affects cognitive function
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Depressive Disorder, Major
- Being tested
- Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime. Receives: Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) | |
| 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. Receives: Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) | |
| 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. Receives: Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG)
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
Measured: Day 1
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.
Measured: Day 1
Memory and Attention task
Listening to audio instructions.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Why it stopped: This study was not intended to be published as a trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Judith M Ford, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758495
- Sponsor's protocol ID
- MHBB-012-17S
- Other IDs
- CX000497
- Status last verified
- Jan 2019
- First submitted
- 7 Nov 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and fMRI Studies of Schizophrenia and Depression
- ClinicalTrials.gov ID
- NCT03758495
- Acronym / sponsor ID
- MHBB-012-17S
- Conditions
- Schizophrenia, Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was not intended to be published as a trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime. |
| Patients with Major Depressive Disorder | – | Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)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. |
| Healthy Controls | – | Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- (All)
- Veterans
- 18-65 years of age
- Negative metal screen for MR scanning
- Corrected to normal vision
Key exclusion criteria (12 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy Controls, Patients with Major Depressive Disorder, Patients with Schizophrenia |
Primary outcome
Electroencephalography (EEG)
Time frame: Day 1
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
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.
Memory and Attention task
Time frame: Day 1
Listening to audio instructions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith M Ford, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Depressive Disorder, Major, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.