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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RX003395 | U.S. NIH Grant/Contract | View source |
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Veterans with mental illness face challenges with community reintegration, including achieving vocational success, attaining their educational goals and going back to school, and maintaining a high quality of life. VA Mental Health Residential Rehabilitation Treatment Programs, Psychosocial Rehabilitation and Recovery Centers and other mental health treatment programs are designed to help Veterans overcome these barriers, but cognitive impairment often seen in Veterans with mental illness limits gains from these settings. Cognitive remediation interventions can be helpful, but they are either "one-size fits all," and thus may not be useful for all Veterans with mental illness, or are too narrow in scope, focusing on specific mental illnesses, limiting generalizability.
This project will test whether an objective neurophysiological biomarker, mismatch negativity (MMN), can better match the "right" Veteran to the "right" cognitive remediation treatment regardless of their specific mental health diagnosis.
This is an observational, non-interventional study. Veterans with mental health diagnoses currently engaged in, or within 6 weeks of discharge from VA Mental Health Residential Rehabilitation Treatment Programs (RRTP), Psychosocial Rehabilitation and Recovery Centers (PRRC), and other mental health treatment settings (inpatient or outpatient mental healthcare) will be recruited. Veterans will have their cognitive functioning assessed. Following this, mismatch negativity (MMN) will be assessed via electroencephalography (EEG). Participants will undergo a 1 hour computerized cognitive training program. They will be interviewed about their attitudes about EEG and computerized cognitive training. They will be followed monthly for a total of 4 months from study entry to assess recovery trajectory. This study aims to enroll 104 Veterans from the VA San Diego Healthcare System.
The Specific Aims of this proposal are 1) Determine whether MMN is related to functioning, psychosocial recovery in VA rehabilitation milieus and programs; 2) Determine whether MMN is linked to cognition and predicts cognitive remediation exercise performance in a heterogeneous group of Veterans with mental illness. The proposal will also assess feasibility and acceptability of using biomarker-guided cognitive rehabilitation interventions in VA mental health rehabilitation settings.
Information gained from this study will help establish a precision-medicine approach towards cognitive rehabilitation for Veterans with mental illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veterans engaged in VA mental health rehabilitation/recovery | Veterans must be within 6 weeks of discharge from or current receive mental health treatment services in a VA San Diego Healthcare System psychosocial rehabilitation and recovery center (PRRC), mental health residential rehabilitation treatment program (RRTP), general mental health outpatient treatment, or recent acute mental health inpatient hospitalization. |
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| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) | Performance on MATRICS Consensus Cognitive Battery at Baseline Visit as measured by the Global Composite T-score (MCCB-C). The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline. The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores, which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome. An MCCB composite T-score of 50 represents population mean with a standard deviation of 10. | Baseline visit |
| Cognitive Training Performance-Number of Levels Completed | Performance on a 1-hour computerized auditory cognitive training exercise as measured by the number of levels completed at the baseline visit. Participants were presented with pairs of frequency-modulated sound "sweeps" and indicated whether they perceived each sweep as becoming higher or lower in pitch. A correct response consisted of accurately identifying the trajectory of both sweeps in the stimulus pair. Sweep duration, frequency range, and interstimulus interval (ISI) become shorter after correct responses, but longer after incorrect responses. Participants progressed through repetition of "levels" of ATCT. Each level consisted of identifying 34 sets of stimuli pairs and each level was completed 3 times, before progressing to the next level. Higher values indicate the subject reliably advanced through more levels of the exercise (i.e., became proficient on trials with shorter frequency-modulated sweep durations), while lower values indicate remaining at easier training levels. | Baseline visit only |
| World Health Organization Disability Schedule (WHODAS 2.0) | Function was assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline, and at the 1, 2 and 3 month follow-up visits. The WHODAS 2.0 has a range 12-60, with higher scores indicating worse outcome. | 3 months |
| WHOQOL-BREF Total Score |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Engagement | The investigators will measure treatment engagement by calculating the proportion of missed and cancelled visits over the course of the study. | 3 months |
| Mismatch Negativity (MMN) |
Inclusion Criteria:
Veterans are currently enrolled in or within 6 weeks of discharge from (as relevant): a VA San Diego Healthcare System (VASDHS) psychosocial rehabilitation and recovery center (PRRC), VASDHS mental health residential rehabilitation treatment program (RRTP), VASDHS acute inpatient hospitalization or VASDHS outpatient mental health treatment
have a DSM-5 mental illness, including:
fluent and literate in English
no impairment in hearing or vision
Exclusion Criteria:
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Veterans are currently enrolled in or within 6 weeks of discharge from (as relevant): a VA San Diego Healthcare System (VASDHS) psychosocial rehabilitation and recovery center (PRRC), VASDHS mental health residential rehabilitation treatment program (RRTP), VASDHS acute inpatient hospitalization or VASDHS outpatient mental health treatment
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| Name | Affiliation | Role |
|---|---|---|
| Yash B. Joshi, MD PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Veterans Engaged in VA Mental Health Rehabilitation/Recovery | Veterans must be within 6 weeks of discharge from or current receive mental health treatment services in a VA San Diego Healthcare System psychosocial rehabilitation and recovery center (PRRC), mental health residential rehabilitation treatment program (RRTP), general mental health outpatient treatment, or recent acute mental health inpatient hospitalization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consented |
| |||||||||||||
| Visit 1 |
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| Completed All Follow-ups |
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Baseline data is for participants who came in for visit 1 since we don't have demographic data for those who were only consented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Veterans Engaged in VA Mental Health Rehabilitation/Recovery | Veterans must be within 6 weeks of discharge from or current receive mental health treatment services in a VA San Diego Healthcare System psychosocial rehabilitation and recovery center (PRRC), mental health residential rehabilitation treatment program (RRTP), general mental health outpatient treatment, or recent acute mental health inpatient hospitalization. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at time of study enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) | Performance on MATRICS Consensus Cognitive Battery at Baseline Visit as measured by the Global Composite T-score (MCCB-C). The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline. The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores, which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome. An MCCB composite T-score of 50 represents population mean with a standard deviation of 10. | Includes those subjects who completed visit 1 (n=86). | Posted | Mean | Standard Deviation | T-Score | Baseline visit |
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From enrollment until end of follow-up, up to approximately 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veterans Engaged in VA Mental Health Rehabilitation/Recovery | Veterans must be within 6 weeks of discharge from or current receive mental health treatment services in a VA San Diego Healthcare System psychosocial rehabilitation and recovery center (PRRC), mental health residential rehabilitation treatment program (RRTP), general mental health outpatient treatment, or recent acute mental health inpatient hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yash Joshi, M.D., Ph.D. | VA San Diego Healthcare System | 619-228-8052 | Yash.Joshi@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2025 | Oct 30, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2024 | Apr 7, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D013313 | Stress Disorders, Post-Traumatic |
| D000098647 | Generalized Anxiety Disorder |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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Electrophysiological data
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) is a 26-item instrument consisting of 4 domains: physical health, psychological health, social relationships and environment. Each item is rated between 1 (not at all) to 5 (completely). The total score is presented between 26 and 156, where higher scores represent higher (better) quality of life. The WHOQOL-BREF was administered at baseline, and at the 1, 2 and 3 month follow-up visits. |
| 3 months |
Mismatch Negativity (MMN) is an automatic, pre-attentive event-related brain potential (ERP) occurring ~100-250 ms after a deviant stimulus breaks a repetitive pattern of standard stimuli. It reflects sensory memory comparison in the auditory cortex and is a key indicator of perceptual accuracy and neural dysfunction. The MMN is the difference wave obtained by subtracting the ERP response of a standard stimulus from a deviant stimulus. MMN amplitudes generally range from -1 to -5 μV and more negative values reflect better perceptual processing. MMN is assessed only during the baseline visit.
| Baseline visit |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary | Cognitive Training Performance-Number of Levels Completed | Performance on a 1-hour computerized auditory cognitive training exercise as measured by the number of levels completed at the baseline visit. Participants were presented with pairs of frequency-modulated sound "sweeps" and indicated whether they perceived each sweep as becoming higher or lower in pitch. A correct response consisted of accurately identifying the trajectory of both sweeps in the stimulus pair. Sweep duration, frequency range, and interstimulus interval (ISI) become shorter after correct responses, but longer after incorrect responses. Participants progressed through repetition of "levels" of ATCT. Each level consisted of identifying 34 sets of stimuli pairs and each level was completed 3 times, before progressing to the next level. Higher values indicate the subject reliably advanced through more levels of the exercise (i.e., became proficient on trials with shorter frequency-modulated sweep durations), while lower values indicate remaining at easier training levels. | Posted | Mean | Standard Deviation | number of levels completed | Baseline visit only |
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| Primary | World Health Organization Disability Schedule (WHODAS 2.0) | Function was assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline, and at the 1, 2 and 3 month follow-up visits. The WHODAS 2.0 has a range 12-60, with higher scores indicating worse outcome. | 78 subjects completed the baseline visit 1 plus all 3 follow-up visits however one subject was missing follow-up 1 WHODAS-2 data and one subject was missing follow-2 WHODAS-2 data. | Posted | Mean | Standard Deviation | score on a rating scale | 3 months |
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| Primary | WHOQOL-BREF Total Score | The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) is a 26-item instrument consisting of 4 domains: physical health, psychological health, social relationships and environment. Each item is rated between 1 (not at all) to 5 (completely). The total score is presented between 26 and 156, where higher scores represent higher (better) quality of life. The WHOQOL-BREF was administered at baseline, and at the 1, 2 and 3 month follow-up visits. | One subject missing Follow-up 1 data | Posted | Mean | Standard Deviation | rating on a scale | 3 months |
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| Other Pre-specified | Treatment Engagement | The investigators will measure treatment engagement by calculating the proportion of missed and cancelled visits over the course of the study. | Posted | Mean | Standard Deviation | proportion of missed/cancelled visits | 3 months |
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| Other Pre-specified | Mismatch Negativity (MMN) | Mismatch Negativity (MMN) is an automatic, pre-attentive event-related brain potential (ERP) occurring ~100-250 ms after a deviant stimulus breaks a repetitive pattern of standard stimuli. It reflects sensory memory comparison in the auditory cortex and is a key indicator of perceptual accuracy and neural dysfunction. The MMN is the difference wave obtained by subtracting the ERP response of a standard stimulus from a deviant stimulus. MMN amplitudes generally range from -1 to -5 μV and more negative values reflect better perceptual processing. MMN is assessed only during the baseline visit. | 86 subjects completed the baseline visit however for the data analyses we only included those who had usable MMN data. | Posted | Mean | Standard Deviation | μV | Baseline visit |
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| 0 |
| 89 |
| 0 |
| 89 |
| 0 |
| 89 |
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| D001008 | Anxiety Disorders |
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| Two Month Follow-up |
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| Three Month Follow-up |
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| Two Month Follow-up |
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| Three Month Follow-up |
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