Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

National Institutes of Health (NIH)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Behavioral: Health and wellness groups; Behavioral: Computer control; Behavioral: Bridging groups; Behavioral: Targeted cognitive training

Study type: Interventional

Funder types: NIH

Identifiers

NCT00930150

N01-MH090001-07

PCC: DSIR AT

N01 MH090001-07

Details and patient eligibility

About

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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:

  1. Learned English before age 12
  2. Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
  3. Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ

• 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

• Psychiatric hospitalization within 8 weeks of random assignment
• Adjustment to antipsychotic treatment within 4 weeks of random assignment
• Currently taking an anticholinergic medication
• DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
• History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Posit Science Intervention

Experimental group

Description:

Participants will receive targeted cognitive training and participate in a bridging group.

Treatment:

Behavioral: Bridging groups

Behavioral: Targeted cognitive training

Control

Active Comparator group

Description:

Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.

Treatment:

Behavioral: Health and wellness groups

Behavioral: Computer control