SchizophreniaNCT04395157
Optimizing Cognitive Remediation
An observational study of Schizophrenia and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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:
- schizophrenia
- schizoaffective disorder
- delusional disorder
- major depressive disorder
Show all 11Show fewer
- bipolar disorder
- generalized anxiety disorder
- PTSD
- fluent and literate in English
- no impairment in hearing or vision
Who cannot join
- active substance use within the last 30 days
- positive urine drug screen conducted as part of the screening process
- have acute/ongoing thoughts of self-harm or harming others
- intellectual disability or a neurocognitive disorder (i.e. dementia)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings
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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Mood Disorders
- Keywords
- Electroencephalography, Cognition, Rehabilitation
- Medical subject headings
- Schizophrenia, Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Dec 2020
- Primary completion1 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Yash B. Joshi, MD PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395157
- Sponsor's protocol ID
- D3395-W
- Other IDs
- 1IK2RX003395
- Status last verified
- Feb 2026
- First submitted
- 12 May 2020
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings
- ClinicalTrials.gov ID
- NCT04395157
- Acronym / sponsor ID
- D3395-W
- Conditions
- Schizophrenia, Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Mood Disorders
- Keywords
- Electroencephalography, Cognition, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- active substance use within the last 30 days
- positive urine drug screen conducted as part of the screening process
- have acute/ongoing thoughts of self-harm or harming others
- intellectual disability or a neurocognitive disorder (i.e. dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
Time frame: Baseline visit
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.
Cognitive Training Performance-Number of Levels Completed
Time frame: Baseline visit only
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.
World Health Organization Disability Schedule (WHODAS 2.0)
Time frame: 3 months
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.
WHOQOL-BREF Total Score
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Yash B. Joshi, MD PhD principal investigator
VA San Diego Healthcare System, San Diego, 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 Stress Disorders, Post-Traumatic, 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 25 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) (time frame: Baseline visit). The study lists 4 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 25 Feb 2026.