Improving Accessibility and Personalization of CR for Schizophrenia

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03576976
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 67
• Locations: 7
• Arms: 2
• Actual Duration (Months): 46.5
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Behavioral: Cognitive Remediation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia
• Actual Study Start Date: Jul 16, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: Hybrid Cognitive Remediation Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Treatment Satisfaction [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.

Secondary Outcome Measures

1. Change From Baseline in Neurocognition [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. The secondary outcome measure is change in the average T score from baseline to post-treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Williamsburg Clinic	Brooklyn	New York	United States	11206
2	Heights Hill Clinic	Brooklyn	New York	United States	11217
3	Mapleton Mental Health Services	Brooklyn	New York	United States	11230
4	Manhattan Psychiatric Center 125th St Outpatient Clinic	New York	New York	United States	10027
5	Inwood Clinic	New York	New York	United States	10040
6	Rockland Psychiatric Center	Orangeburg	New York	United States	10962
7	Creedmoor Psychiatric Center	Queens Village	New York	United States	11427

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Alice Medalia, PhD, New York State Psychiatric Institute

Study Documents (Full-Text)

• Study Protocol - May 24, 2018
• Statistical Analysis Plan - May 24, 2018

More Information

Publications

None provided.

• Responsible Party: Alice Medalia, Professor of Medical Psychology in Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03576976
• Other Study ID Numbers: 7638; 1P50MH115843-01
• First Posted: Jul 5, 2018
• Last Update Posted: Jul 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alice Medalia, Professor of Medical Psychology in Psychiatry, New York State Psychiatric Institute: Cognitive Remediation
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Clinic-based Cognitive Remediation	Hybrid Cognitive Remediation
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	27	28
COMPLETED	18	17
NOT COMPLETED	9	11

Baseline Characteristics

Arm/Group Title	Clinic-based Cognitive Remediation	Hybrid Cognitive Remediation	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	27	28	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.32 (12.73)	48.99 (12.05)	45.71 (12.73)
Sex: Female, Male (Count of Participants)
Female	7 25.9%	9 32.1%	16 29.1%
Male	20 74.1%	19 67.9%	39 70.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 33.3%	8 28.6%	17 30.9%
Not Hispanic or Latino	18 66.7%	20 71.4%	38 69.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 3.6%	1 1.8%
Asian	0 0%	2 7.1%	2 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	18 66.7%	14 50%	32 58.2%
White	7 25.9%	11 39.3%	18 32.7%
More than one race	1 3.7%	0 0%	1 1.8%
Unknown or Not Reported	1 3.7%	0 0%	1 1.8%
IQ Estimate (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	92.67 (10.32)	90.86 (10.82)	91.75 (10.52)

Outcome Measures

1. Primary Outcome

Title	Treatment Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clinic-based Cognitive Remediation	Hybrid Cognitive Remediation
Arm/Group Description	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.	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.
Measure Participants	18	17
Mean (Standard Deviation) [score on a scale]	5.25 (0.97)	5.32 (0.98)

2. Secondary Outcome

Title	Change From Baseline in Neurocognition
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Clinic-based Cognitive Remediation	Hybrid Cognitive Remediation
Arm/Group Description	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.	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.
Measure Participants	17	15
Mean (Standard Deviation) [T Score]	-1.49 (3.6)	0.97 (6.56)

Adverse Events

Time Frame	Adverse event data were collected for each individual from baseline to post-treatment, approximately 15 weeks.
Arm/Group Title	Clinic-based Cognitive Remediation		Hybrid Cognitive Remediation
Arm/Group Description	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.		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.
All Cause Mortality
	Clinic-based Cognitive Remediation		Hybrid Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/28 (0%)
Serious Adverse Events
	Clinic-based Cognitive Remediation		Hybrid Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Clinic-based Cognitive Remediation		Hybrid Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/28 (0%)

Limitations/Caveats

COVID-19 pandemic limited post-treatment data collection at the conclusion of the trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.