Recruiting

Rehabilitation

Sponsor:

VA Office of Research and Development

Code:

NCT06586164

Conditions

Schizophrenia

Psychosis

Serious Mental Illness

PTSD

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Targeted Cognitive Training

Study Details

Brief 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). 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.

Conditions

Schizophrenia

Psychosis

Serious Mental Illness

PTSD

Schizoaffective Disorder

Study ID

NCT06586164

Start date

Feb 25, 2025

Status verified date

Jan, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TCT + TAU

Subjects will complete 30 hours of Targeted Cognitive Training (TCT) in addition to their Treatment as Usual (TAU)

no intervention: TAU

Subjects will participate in their standard Treatment as Usual (TAU) PRRC program

Interventions

Targeted Cognitive Training

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.

Primary outcome measure

  • Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 22 weeks ]
  • Cognition - Matrics Consensus Cognitive Battery (MCCB) [ Time Frame: 22 weeks ]
  • Function - Functional Capacity: UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B) [ Time Frame: 22 weeks ]
  • Function - Psychosocial Recovery: World Health Organization Disability Schedule 2.0 (WHODAS) [ Time Frame: 22 weeks ]

Central Contacts and Locations

Central contacts

Joyce Sprock, BS

(858) 552-8585joyce.sprock@va.gov

Abigail A Mack

(858) 642-6492abigail.mack@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Gregory Light, PhD

619-227-4734gregory.light@va.gov

Yash B Joshi, MD PhD

(858) 642-3827Yash.Joshi@va.gov

Principal Investigator:

Gregory Light, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • schizophrenia
  • psychosis
  • cognition
  • EEG
  • Serious mental illness
  • PTSD
  • Schizoaffective disorder
  • Bipolar disorder
  • clinical symptoms
  • function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-30.