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| ID | Type | Description | Link |
|---|---|---|---|
| N01-MH090001-07 | |||
| PCC: DSIR AT | |||
| N01MH090001 | U.S. NIH Grant/Contract | View source |
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This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.
Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with decreased benefit from psychiatric rehabilitation and problems with treatment adherence, socialization, employment, quality of life, and relapse. Researchers believe that the failure of medication to improve cognition may occur because medication treatment lacks cognitive stimulation. Cognitive remediation programs are a way to provide that stimulation, and they have shown moderate efficacy in improving cognition in people with schizophrenia. Implementing these cognitive remediation programs as part of schizophrenia treatment has occurred only at individual sites with highly trained research personnel. This study will test whether cognitive remediation programs for schizophrenia can be feasibly implemented at a network of sites that do not specialize in cognitive remediation research. This pilot study will gather preliminary efficacy data, but a larger study is required to draw definitive conclusions about treatment effects.
Participation in this study will last approximately 8 weeks. Participants will be randomly assigned to the Posit Science intervention group or the control group. Those in the Posit Science group will receive targeted cognitive training (TCT)-40 hours of adaptive computer exercises-and participate in a weekly bridging group that helps participants apply cognitive skills to everyday contexts. Length of the TCT may vary, depending on the availability of participants to complete the exercises. Those in the control group will play commercially available video games for the same number of hours and participate in a weekly health and wellness group. All participants will undergo assessments at baseline, mid-treatment, and post-treatment. Assessments will include self-report questionnaires and clinical interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posit Science Intervention | Experimental | Participants will receive targeted cognitive training and participate in a bridging group. |
|
| Control | Active Comparator | Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted cognitive training | Behavioral | Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a multisite trial using cognitive remediation | Measured at post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score | Measured at post-treatment |
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Inclusion Criteria:
Demonstrates adequate decisional capacity to make a choice about participating in the research study
Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
Meets all of the following cognitive performance and English language criteria:
Able to state specific goals relevant to the intervention that participant would like to achieve
Able to participate in the computerized intervention, based on the judgment of the investigator
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Keefe, PhD | Duke University | Principal Investigator |
| T. Scott Stroup, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University/Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33539561 | Derived | Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2. | |
| 28433500 | Derived | Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20. |
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| Computer control | Behavioral | Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content |
|
| Bridging groups | Behavioral | Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization |
|
| Health and wellness groups | Behavioral | Weekly group meetings that teach participants health and wellness skills |
|
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| University of Iowa Hospital | Iowa City | Iowa | 52242 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| University of Minnesota School of Medicine | Minneapolis | Minnesota | 55454 | United States |
| The University of North Carolina | Chapel Hill | North Carolina | 27599-7160 | United States |
| Philadelphia VA Medical Center-116A | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| 22687548 | Derived | Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. J Clin Psychiatry. 2012 Jul;73(7):1016-22. doi: 10.4088/JCP.11m07100. Epub 2012 May 15. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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