Improving Accessibility and Personalization of CR for Schizophrenia
2 other identifiers
interventional
67
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jul 2018
Typical duration for not_applicable schizophrenia
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedResults Posted
Study results publicly available
February 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedJuly 13, 2022
June 1, 2022
2.5 years
May 25, 2018
December 8, 2021
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Through study completion, 15 weeks
Secondary Outcomes (1)
Change From Baseline in Neurocognition
Baseline and 15 weeks
Study Arms (2)
Clinic-based Cognitive Remediation
ACTIVE COMPARATORClinic-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.
Hybrid Cognitive Remediation
EXPERIMENTALHybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unremitted substance dependence
- Neurological illness affecting brain functioning
- Traumatic brain injury within 2 years
- Auditory or visual impairment (uncorrected)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Williamsburg Clinic
Brooklyn, New York, 11206, United States
Heights Hill Clinic
Brooklyn, New York, 11217, United States
Mapleton Mental Health Services
Brooklyn, New York, 11230, United States
Manhattan Psychiatric Center 125th St Outpatient Clinic
New York, New York, 10027, United States
Inwood Clinic
New York, New York, 10040, United States
Rockland Psychiatric Center
Orangeburg, New York, 10962, United States
Creedmoor Psychiatric Center
Queens Village, New York, 11427, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
COVID-19 pandemic limited post-treatment data collection at the conclusion of the trial.
Results Point of Contact
- Title
- Dr. Alice Medalia
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Medalia, PhD
New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medical Psychology in Psychiatry
Study Record Dates
First Submitted
May 25, 2018
First Posted
July 5, 2018
Study Start
July 16, 2018
Primary Completion
December 31, 2020
Study Completion
May 30, 2022
Last Updated
July 13, 2022
Results First Posted
February 2, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- A list of all data expected to be collected in the project will be submitted within 6 months of award. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
- Access Criteria
- Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.
Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT) and the NIMH Database of Cognitive Training and Remediation Studies (DoCTRS). Data will include baseline demographic data, and baseline and post raw data derived from cognitive, quality of life, functioning and symptom measures.