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Ford Rumination and Mindfulness Merit

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ClinicalTrials.gov Identifier: NCT03758495
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Judith Ford, San Francisco Veterans Affairs Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment
Schizophrenia Depressive Disorder, Major Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and Functional Magnetic Resonance Imaging (fMRI) Studies of Schizophrenia and Depression
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Schizophrenia
Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime.
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: 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.




Primary Outcome Measures :
  1. Electroencephalography (EEG) [ Time Frame: Day 1 ]
    Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.

  2. 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.

  3. Memory and Attention task [ Time Frame: Day 1 ]
    Listening to audio instructions.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Criteria

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 veterans):

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758495


Contacts
Contact: Alison Boos, BA (415) 221-4810 ext 26403 bieegl.ucsf@gmail.com
Contact: Brian Roach, MS 415-221-4810 ext 23789 bieegl.ucsf@gmail.com

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Alison Boos, BA    415-221-4810 ext 26403    bieegl.ucsf@gmail.com   
Contact: Brian Roach, MS    415-221-4810 ext 23789    bieegl.ucsf@gmail.com   
Principal Investigator: Judy Ford, PhD         
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
Investigators
Principal Investigator: Judy Ford, PhD San Francisco VA Medical Center

Responsible Party: Judith Ford, Research Scientist and Professor of Psychiatry, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03758495     History of Changes
Other Study ID Numbers: CX000497
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms