Trial Outcomes & Findings for Improving Accessibility and Personalization of CR for Schizophrenia (NCT NCT03576976)

Last Updated: 2022-07-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Through study completion, 15 weeks

Results posted on

2022-07-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	27	28
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Accessibility and Personalization of CR for Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinic-based Cognitive Remediation n=27 Participants 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 n=28 Participants 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 n=55 Participants Total of all reporting groups
Age, Continuous	42.32 years STANDARD_DEVIATION 12.73 • n=5 Participants	48.99 years STANDARD_DEVIATION 12.05 • n=7 Participants	45.71 years STANDARD_DEVIATION 12.73 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
IQ Estimate	92.67 units on a scale STANDARD_DEVIATION 10.32 • n=5 Participants	90.86 units on a scale STANDARD_DEVIATION 10.82 • n=7 Participants	91.75 units on a scale STANDARD_DEVIATION 10.52 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, 15 weeks

Outcome measures

Outcome measures
Measure	Clinic-based Cognitive Remediation n=18 Participants 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 n=17 Participants 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.
Treatment Satisfaction	5.25 score on a scale Standard Deviation 0.97	5.32 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Clinic-based Cognitive Remediation n=17 Participants 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 n=15 Participants 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.
Change From Baseline in Neurocognition	-1.49 T Score Standard Deviation 3.6	0.97 T Score Standard Deviation 6.56

Adverse Events

Clinic-based Cognitive Remediation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hybrid Cognitive Remediation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alice Medalia

New York State Psychiatric Institute

Phone: 646-774-8482

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place