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N/A N=55 Randomized Single-blind Treatment

Improving Accessibility and Personalization of CR for Schizophrenia

Schizophrenia · Schizoaffective Disorder

Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Treatment Satisfaction — 5.25; 5.32 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cognitive Remediation (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Dec 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Satisfaction
5.25; 5.32
SECONDARY
Change From Baseline in Neurocognition
-1.49; 0.97

Summary

This project will explore adaptations of treatments for schizophrenia, with the goal of optimizing their effectiveness in real-world clinical settings and readiness for broad deployment. Schizophrenia is associated with cognitive deficits that negatively impact essential areas of daily functioning. NY State Office of Mental Health (OMH) is the first and largest state system of care to implement a statewide program of cognitive remediation (CR), an evidence-based practice for improving cognition and aiding functional recovery. Through Cognitive Remediation to Promote Recovery (CR2PR), CR is now offered in outpatient programs, with plans to expand to more services and further adapt implementation to improve treatment outcomes. This project will work directly with OMH clinics and clinicians to build upon and improve current CR delivery methods. This project will study the impact of two adaptations. One focuses on increasing the accessibility of the program, which participants report is limited by the requirement of twice weekly attendance. This project will compare the feasibility and acceptability of delivering CR in either two clinic-based sessions (Clinic) or one clinic and one remote session (Hybrid) per week. Qualitative interviews will be conducted with stakeholders to explore the impact of the adaptation. The second adaptation is intended to improve personalization of CR by systematically accounting for individual differences in neurocognitive needs. Drawing upon convergent evidence for tailoring CR based on need for early auditory processing (EAP) training, this project examines whether integrating a measure of EAP into the current baseline assessment facilitates personalization of the menu of restorative computer-based exercises used in CR. Feasibility parameters and qualitative/quantitative data analyses of facilitators and barriers to Hybrid CR delivery will together inform further treatment refinement and the design of a larger effectiveness trial of Clinic versus Hybrid CR. This project will examine how EAP assessment is employed by practitioners to personalize the CR treatment plan and examine if EAP improvement is associated with cognitive outcomes in public practice CR settings. Finally cognitive, functional, and service use outcomes in Hybrid versus Clinic CR will be compared.

Eligibility Criteria

Inclusion Criteria

  • Referred for participation in Cognitive Remediation to Promote Recovery by outpatient clinic teams
  • A primary DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Verbal IQ estimate of 70 or above
  • Stabilized on any psychotropic medication
  • English-speaking

Exclusion Criteria

  • Unremitted substance dependence
  • Neurological illness affecting brain functioning
  • Traumatic brain injury within 2 years
  • Auditory or visual impairment (uncorrected)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03576976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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