NCT03576976

Improving Accessibility and Personalization of CR for Schizophrenia

Completed NA Results posted Last updated 13 July 2022

What this trial tests

NA trial testing Cognitive Remediation in Schizophrenia in 67 participants. Completed in 30 May 2022.

Timeline

16 July 2018

Primary endpoint
31 December 2020

30 May 2022

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	67
Start date	16 July 2018
Primary completion	31 December 2020
Estimated completion	30 May 2022
Sites	7 locations across United States

Drugs / interventions tested

• Cognitive Remediation — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 65, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Satisfaction Primary · Through study completion, 15 weeks

Treatment satisfaction will be measured using a self-report Likert-type rating scale questionnaire reflecting the specific components of the treatments used for this study. The outcome measure will be an average of the scale items, ranging from 1 to 6, with 1 reflecting strong dissatisfaction with the treatment and 6 reflecting strong satisfaction with the treatment.

Group	Value	95% CI
Clinic-based Cognitive Remediation	5.25	± 0.97
Hybrid Cognitive Remediation	5.32	± 0.98

Change From Baseline in Neurocognition Secondary · Baseline and 15 weeks

Neurocognition will be measured with subtests from the Brief Assessment of Cognition in Schizophrenia (BACS): Verbal Memory (verbal memory and learning), Digit Sequencing (working memory), Symbol Coding (speed of processing), and Tower of London (executive function) and the Continuous Performance Test - Identical Pairs (CPT-IP; attention/vigilance). A T score for each subtest is obtained where the population mean is 50 and the standard deviation is 10. For all subtests higher scores indicate better outcome. An average T score is generated to capture neurocognition at each assessment time point

Group	Value	95% CI
Clinic-based Cognitive Remediation	-1.49	± 3.6
Hybrid Cognitive Remediation	0.97	± 6.56

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility and acceptability of remotely accessed cognitive remediation for schizophrenia in public health settings.
   Medalia A, Saperstein AM, Stefancic A, Meyler S, et al · · 2021 · cited 19× · PMID 33962354 · DOI 10.1016/j.psychres.2021.113956
2. Feasibility and clinical utility of using the tone matching test for assessment of early auditory processing in schizophrenia.
   Medalia A, Saperstein A, Javitt DC, Qian M, et al · · 2023 · cited 5× · PMID 36907004 · DOI 10.1016/j.psychres.2023.115152
3. Disparities in technology literacy and access negatively impact cognitive remediation scalability.
   Arlia C, Saperstein AM, Meyler S, Styke S, et al · · 2022 · cited 2× · PMID 35501204 · DOI 10.1016/j.schres.2022.04.006