SchizophreniaNCT06586164
Enhancing Rehabilitation for Veterans With Serious Mental Illness
A study testing Targeted Cognitive Training in people with Schizophrenia and Psychosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Schizophrenia, Psychosis, Serious Mental Illness
- What is being tested?
- Targeted Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with SMI (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, PTSD) being treated at PRRCs or co-located rehabilitative services.
- Age 18 and 83 years.
- Fluency in spoken and written English.
- Ability to detect 1000 Hz tones binaurally at a 40-dB sound pressure level.
- Ability to see with an acuity of 20/40 with both eyes tested together (corrected if applicable) by a standard printed Snellen eye chart reading card.
Who cannot join
- Estimated premorbid IQ below 70, as estimated via the WRAT-4 Reading subtest.
- Active substance use other than cannabis within the last 30 days as determined by CPRS review, self- report, or positive urine drug screen (obtained as part of the screening process).
- History of significant medical or neurological illness.
- Inability to comprehend or provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Gregory Light, PhD, 619-227-4734, gregory.light@va.gov
Yash B Joshi, MD PhD, (858) 642-3827, Yash.Joshi@va.gov
About this study
Official title: Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.
Read the detailed description
This application addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This application aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning.
TCT is a computerized intervention designed to sharpen the acuity and fidelity of sensory information processing through specific exercises that systematically increase demands on early perceptual and attentive processes. For many participants, TCT leads to "bottom-up" gains in perceptual functioning that lead to improvements in verbal learning and memory after 20-30h. While these benefits of TCT are evident at the group level, nearly half of all patients fail to show cognitive gains, even after extended 40-100h courses of TCT. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.
Enrolled patients complete clinical, cognitive and functional measures and candidate EEG biomarkers at baseline, and then are assigned to Treatment As Usual (TAU) vs. TCT+TAU arms (n=40/group) using stratified random sampling. TAU consists of participation in the standard PRRC programming that includes visits with PRRC clinicians, recovery coaching, groups and psychotherapy, peer services, and supported employment. Subjects randomized to TCT + TAU will also complete 30 hours of TCT consisting of three one-hour training sessions per week. Repeat assessment will occur after TCT session #10, 20 and 30 (or after the equivalent number of weeks have passed for TAU) and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains.
This project will evaluate whether PRRC outpatients receiving 30 hours of TCT will exhibit significant improvements in clinical symptoms and cognition along with psychosocial functioning and quality of life compared with the TAU group. The investigators also hypothesize that favorable responses to 30 hours of TCT will be predicted by behavioral, cognitive, and EEG-based biomarkers measured at the beginning of the study. Finally the investigators will examine the acceptability of TCT and biomarker testing, as well as barriers and facilitators to implementation from the perspective of Veterans and PRRC clinicians based on feedback from study participants.
- Conditions
- Schizophrenia, Psychosis, Serious Mental Illness, PTSD, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Targeted Cognitive Training
- Keywords
- schizophrenia, psychosis, cognition, EEG, Serious mental illness, PTSD, Schizoaffective disorder, Bipolar disorder, clinical symptoms, function
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Stress Disorders, Post-Traumatic, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive TrainingBehavioural
Also called TCT
TCT is a computer-based cognitive training program in which participants train on progressively more difficult auditory processing exercises in order to improve speed, accuracy and fidelity of auditory information processing in order to generate gains in cognition and functioning.
| Study group | Role | What they receive |
|---|---|---|
| TCT + TAU | Active comparator | Subjects will complete 30 hours of Targeted Cognitive Training (TCT) in addition to their Treatment as Usual (TAU) Receives: Behavioral: Targeted Cognitive Training |
| TAU | No intervention | Subjects will participate in their standard Treatment as Usual (TAU) PRRC program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS)
Change from baseline clinical symptoms Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) will used to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of SZ. The PANSS is a 30-item scale arranged as 7 positive symptom subscale items, 7 negative symptom subscale items, and 16 general psychopathology symptom items. Each item has a definition and a basis for rating. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). On the PANSS lower values are considered to be a better outcome.
Measured: 22 weeks
Cognition - Matrics Consensus Cognitive Battery (MCCB)
Change from baseline cognition Matrics Consensus Cognitive Battery (MCCB) performance
Change in Matrics Consensus Cognitive Battery (MCCB) performance from baseline is the outcome measure for cognition (using age- and gender-corrected T scores). The MCCB measures 7 cognitive domains: speed of processing, attention/vigilance, working memory (verbal and nonverbal), verbal learning, visual learning, reasoning/ problem solving and social cognition. MCCB verbal learning T-score is the primary cognitive outcome measure. Other MCCB domain T- scores will be used in secondary analyses. On the MCCB higher scores are indicative of better outcome.
Measured: 22 weeks
Function - Functional Capacity: UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B)
Functional Capacity will be assessed with the UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B) at study entry and assessment intervals. The UPSA takes ~15 min to complete and incorporates role play to assess functional capacity in four broad domains: planning recreational activities, finances, communication and transportation. Raw scores on each subtest are transformed into a standardized subscale scores (0-25), which are summated to an overall
Measured: 22 weeks
Function - Psychosocial Recovery: World Health Organization Disability Schedule 2.0 (WHODAS)
World Health Organization Disability Schedule 2.0 (WHODAS) will be used to assess psychosocial recovery. This detailed assessment consists of a 36-item questionnaire, where patients rate various aspects on a 5-point Likert scale. It covers six critical domains: cognition, mobility, self-care, social interactions, life activities, and societal participation. The WHODAS 2.0 will be used as an outcome measure for psychosocial recovery. Lower scores indicate better outcome on the WHODAS 2.0.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Feb 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to Targeted Cognitive Training (TCT) + Treatment as Usual (TAU) or Treatment as Usual (TAU)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Gregory Light, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586164
- Sponsor's protocol ID
- D5058-R
- Other IDs
- H230094
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 30 Jan 2026
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training
- ClinicalTrials.gov ID
- NCT06586164
- Acronym / sponsor ID
- D5058-R
- Conditions
- Schizophrenia, Psychosis, Serious Mental Illness, PTSD, Schizoaffective Disorder, Bipolar Disorder
- Keywords
- schizophrenia, psychosis, cognition, EEG, Serious mental illness, PTSD, Schizoaffective disorder, Bipolar disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, San Diego
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.
Detailed description
This application addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This application aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning.
TCT is a computerized intervention designed to sharpen the acuity and fidelity of sensory information processing through specific exercises that systematically increase demands on early perceptual and attentive processes. For many participants, TCT leads to "bottom-up" gains in perceptual functioning that lead to improvements in verbal learning and memory after 20-30h. While these benefits of TCT are evident at the group level, nearly half of all patients fail to show cognitive gains, even after extended 40-100h courses of TCT. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.
Enrolled patients complete clinical, cognitive and functional measures and candidate EEG biomarkers at baseline, and then are assigned to Treatment As Usual (TAU) vs. TCT+TAU arms (n=40/group) using stratified random sampling. TAU consists of participation in the standard PRRC programming that includes visits with PRRC clinicians, recovery coaching, groups and psychotherapy, peer services, and supported employment. Subjects randomized to TCT + TAU will also complete 30 hours of TCT consisting of three one-hour training sessions per week. Repeat assessment will occur after TCT session #10, 20 and 30 (or after the equivalent number of weeks have passed for TAU) and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains.
This project will evaluate whether PRRC outpatients receiving 30 hours of TCT will exhibit significant improvements in clinical symptoms and cognition along with psychosocial functioning and quality of life compared with the TAU group. The investigators also hypothesize that favorable responses to 30 hours of TCT will be predicted by behavioral, cognitive, and EEG-based biomarkers measured at the beginning of the study. Finally the investigators will examine the acceptability of TCT and biomarker testing, as well as barriers and facilitators to implementation from the perspective of Veterans and PRRC clinicians based on feedback from study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to Targeted Cognitive Training (TCT) + Treatment as Usual (TAU) or Treatment as Usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| TCT + TAU | Active comparator | Behavioral: Targeted Cognitive TrainingSubjects will complete 30 hours of Targeted Cognitive Training (TCT) in addition to their Treatment as Usual (TAU) |
| TAU | No intervention | –Subjects will participate in their standard Treatment as Usual (TAU) PRRC program |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans with SMI (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, PTSD) being treated at PRRCs or co-located rehabilitative services.
- Age 18 and 83 years.
- Fluency in spoken and written English.
- Ability to detect 1000 Hz tones binaurally at a 40-dB sound pressure level.
- Ability to see with an acuity of 20/40 with both eyes tested together (corrected if applicable) by a standard printed Snellen eye chart reading card.
Key exclusion criteria (4 listed)
- Estimated premorbid IQ below 70, as estimated via the WRAT-4 Reading subtest.
- Active substance use other than cannabis within the last 30 days as determined by CPRS review, self- report, or positive urine drug screen (obtained as part of the screening process).
- History of significant medical or neurological illness.
- Inability to comprehend or provide informed consent.
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 |
|---|---|---|
| Targeted Cognitive TrainingAlso: TCTTCT is a computer-based cognitive training program in which participants train on progressively more difficult auditory processing exercises in order to improve speed, accuracy and fidelity of auditory information processing in order to generate gains in cognition and functioning. | Behavioural | TCT + TAU |
Primary outcome
Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS)
Time frame: 22 weeks
Change from baseline clinical symptoms Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) will used to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of SZ. The PANSS is a 30-item scale arranged as 7 positive symptom subscale items, 7 negative symptom subscale items, and 16 general psychopathology symptom items. Each item has a definition and a basis for rating. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). On the PANSS lower values are considered to be a better outcome.
Cognition - Matrics Consensus Cognitive Battery (MCCB)
Time frame: 22 weeks
Change from baseline cognition Matrics Consensus Cognitive Battery (MCCB) performance Change in Matrics Consensus Cognitive Battery (MCCB) performance from baseline is the outcome measure for cognition (using age- and gender-corrected T scores). The MCCB measures 7 cognitive domains: speed of processing, attention/vigilance, working memory (verbal and nonverbal), verbal learning, visual learning, reasoning/ problem solving and social cognition. MCCB verbal learning T-score is the primary cognitive outcome measure. Other MCCB domain T- scores will be used in secondary analyses. On the MCCB higher scores are indicative of better outcome.
Function - Functional Capacity: UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B)
Time frame: 22 weeks
Functional Capacity will be assessed with the UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B) at study entry and assessment intervals. The UPSA takes ~15 min to complete and incorporates role play to assess functional capacity in four broad domains: planning recreational activities, finances, communication and transportation. Raw scores on each subtest are transformed into a standardized subscale scores (0-25), which are summated to an overall
Function - Psychosocial Recovery: World Health Organization Disability Schedule 2.0 (WHODAS)
Time frame: 22 weeks
World Health Organization Disability Schedule 2.0 (WHODAS) will be used to assess psychosocial recovery. This detailed assessment consists of a 36-item questionnaire, where patients rate various aspects on a 5-point Likert scale. It covers six critical domains: cognition, mobility, self-care, social interactions, life activities, and societal participation. The WHODAS 2.0 will be used as an outcome measure for psychosocial recovery. Lower scores indicate better outcome on the WHODAS 2.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- 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.
Gregory Light, 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?
A study testing Targeted Cognitive Training in people with Schizophrenia and Psychosis, 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 5 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: looking for participants now, as of the sponsor's last update on 30 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joyce Sprock, BS ((858) 552-8585 ext. 2261, joyce.sprock@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS) (time frame: 22 weeks). 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 30 Jan 2026.