Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing

Summary

The primary aim of this study is to provide confirmation that Cognitive Remediation (CR) for schizophrenia, when personalized based on pre-treatment assessment of early auditory processing ability, facilitates improved cognitive and functional outcomes. Additional aims of this study address the mechanisms of treatment effect. The study uses a repeated-measures randomized trial design.

Enrollment will be by invitation, open to individuals receiving services at select community behavioral health facilities where CR is offered. Clients who are eligible for the service, who agree to participate in research and who meet inclusion/exclusion criteria will be assessed on outcome measures and categorized via performance on the Tone Matching (TM) test, as EAP impaired (EAP-) or EAP intact (EAP+). Subsequently, EAP- and EAP+ subgroups will be randomized to either (1) Brain Basics (BB; n = 100), an EAP-enhanced CR approach or (2) Brain Training (BT; n = 100), a routine CR approach. Participants will be invited to participate in a second pre-treatment assessment to measure electrophysiologic responses to auditory stimuli. All participants will be scheduled to repeat outcome measure assessments after treatment and after a follow-up period. The EAP- group receiving BB will be invited to repeat electrophysiological paradigms post-treatment to investigate mechanisms of change related to the CR intervention. Verbal learning will be the primary outcome with functional capacity the secondary outcome. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

BEHAVIORAL

Brain Basics

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

BEHAVIORAL

Brain Training

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Alice Medalia, Ph.D. · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

68 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-14

Primary Completion

2025-10-24

Completion

2025-12-08

Countries

• United States

Study Locations