Generalized Anxiety Disorder, Mood Disorders, Schizophrenia, Stress Disorders, Post-Traumatic
Conditions
Keywords
Electroencephalography, Cognition, Rehabilitation
Brief 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. 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.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * schizophrenia * schizoaffective disorder * delusional disorder * major depressive disorder * bipolar disorder * generalized anxiety disorder * PTSD * fluent and literate in English * no impairment in hearing or vision
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) | 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 | 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) | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYash B. Joshi, MD PhD
VA San Diego Healthcare System, San Diego, CA
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 12.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 89 |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
None listed