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Improving Accessibility and Personalization of CR for Schizophrenia

Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576976
Enrollment
67
Registered
2018-07-05
Start date
2018-07-16
Completion date
2022-05-30
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

Cognitive Remediation

Brief 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.

Detailed description

Cognitive remediation (CR) is an evidence-based practice to treat the pervasive and significant cognitive deficits that contribute to functional decline in schizophrenia. The New York State Office of Mental Health (OMH) has teamed with the Principal Investigator to be the first, and largest state system of care to implement a statewide program of CR tied to recovery programming. Through Cognitive Remediation to Promote Recovery (CR2PR), CR is now offered in outpatient programs throughout the state, with plans to expand to more services and further adapt implementation to improve treatment outcomes. To proceed systematically, this project will work directly with CR2PR programs, guided by practice-based evidence gathered during CR2PR to build upon and improve current CR delivery methods in two ways. 1. Ongoing program evaluation indicates that the burden of attending clinic twice per week for CR limits the number of people who enroll. This project will test the feasibility and collect preliminary data on the effectiveness of personalized CR delivery that involves one clinic visit and one remote session per week. Demonstrating the effectiveness of incorporating remotely delivered CR would double the number of patients who could access the OMH CR program and reduce treatment costs. 2. Current effect sizes for cognition and functional outcomes may remain limited if personalization, mechanisms of action, and relevant targets are not better addressed. Given evidence that early auditory information processing ability (EAP) works as a neurobehavioral marker of need for sensory processing training, this study will test the potential to use baseline EAP assessment to tailor CR, incorporating EAP with other cognitive skills training as clinically indicated. The ultimate goal of integrating scalable assessment practices to personalize CR is to improve recovery outcomes. The study will use a repeated measures, randomized design. Eligible participants who are referred to CR2PR will complete a routine baseline neurocognitive assessment with the addition of a EAP measure, and will then be randomized to either all-clinic CR (Clinic) or clinic+remote (Hybrid) CR. The Clinic research arm consists of 30 sessions delivered twice weekly in a group format of up to 8 participants with rolling admission. The Hybrid condition consists of 15 clinic sessions in the above format, and independent homework on cognitive exercises for 60 minutes per week for 15 weeks using a laptop, PC or tablet available to them. All clinic sessions consist of 45 minutes of working on 3-4 computerized exercises selected by a clinician from a menu of web-based programs to improve the cognitive functions identified as impaired on the assessment. Computer exercises are followed by 15 minute manualized discussion groups based on the concept of Bridging. All participants will complete a treatment satisfaction survey and will be re-tested on outcome measures approximately 1 week following end of treatment. Additional data on the feasibility and acceptability of the Hybrid approach will be gathered through a qualitative interview with participants at treatment endpoint.

Interventions

BEHAVIORALCognitive Remediation

Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment SatisfactionThrough study completion, 15 weeksTreatment 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.

Secondary

MeasureTime frameDescription
Change From Baseline in NeurocognitionBaseline and 15 weeksNeurocognition 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. The secondary outcome measure is change in the average T score from baseline to post-treatment.

Countries

United States

Participant flow

Pre-assignment details

Enrolled participants were screened and assessed on outcome measures prior to randomization. Those who did not complete baseline assessments due to lost contact or no longer meeting inclusion criteria were not assigned to a treatment condition and were exited from the study.

Participants by arm

ArmCount
Clinic-based Cognitive Remediation
Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions. Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life.
27
Hybrid Cognitive Remediation
Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice. Cognitive Remediation: Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life.
28
Total55

Baseline characteristics

CharacteristicClinic-based Cognitive RemediationHybrid Cognitive RemediationTotal
Age, Continuous42.32 years
STANDARD_DEVIATION 12.73
48.99 years
STANDARD_DEVIATION 12.05
45.71 years
STANDARD_DEVIATION 12.73
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants8 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants20 Participants38 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
IQ Estimate92.67 units on a scale
STANDARD_DEVIATION 10.32
90.86 units on a scale
STANDARD_DEVIATION 10.82
91.75 units on a scale
STANDARD_DEVIATION 10.52
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
18 Participants14 Participants32 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
7 Participants11 Participants18 Participants
Sex: Female, Male
Female
7 Participants9 Participants16 Participants
Sex: Female, Male
Male
20 Participants19 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 28
other
Total, other adverse events
0 / 270 / 28
serious
Total, serious adverse events
0 / 270 / 28

Outcome results

Primary

Treatment Satisfaction

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.

Time frame: Through study completion, 15 weeks

ArmMeasureValue (MEAN)Dispersion
Clinic-based Cognitive RemediationTreatment Satisfaction5.25 score on a scaleStandard Deviation 0.97
Hybrid Cognitive RemediationTreatment Satisfaction5.32 score on a scaleStandard Deviation 0.98
Secondary

Change From Baseline in Neurocognition

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. The secondary outcome measure is change in the average T score from baseline to post-treatment.

Time frame: Baseline and 15 weeks

Population: The analysis population includes all participants who completed the intervention phase who were able to attend a post-treatment assessment.

ArmMeasureValue (MEAN)Dispersion
Clinic-based Cognitive RemediationChange From Baseline in Neurocognition-1.49 T ScoreStandard Deviation 3.6
Hybrid Cognitive RemediationChange From Baseline in Neurocognition0.97 T ScoreStandard Deviation 6.56

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026