Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04554121
Other study ID # 7982
Secondary ID 1R01MH123561-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 14, 2020
Est. completion date May 1, 2024

Study information

Verified date August 2023
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This personalized Cognitive Remediation (CR) confirmatory efficacy trial will be conducted at behavioral health facilities offering CR, located within the New York metropolitan area. Participants for this study will include adults diagnosed with schizophrenia or schizoaffective disorder, age 18-68, who have identified cognitive health as a pertinent treatment for recovery goal attainment and are seeking CR services. Individuals referred to CR may be referred for research by their treating clinician or may be self-referred. Consented individuals will receive a numeric study ID which will be used to de-identify all data collected for research. Time 1 (baseline) outcomes assessments conducted by the research team include early auditory processing (EAP) ability, cognitive ability, and functioning. Participants will be classified as EAP impaired (EAP-) or EAP intact (EAP+). Following completion of Time 1 assessments, assignment to treatment condition will be stratified by EAP ability and randomized to Brain Basics (BB, n=100) or Brain Training (BT, n=100). Participants will be invited to participate in a separate EEG assessment of Mismatch Negativity (MMN). CR will be conducted by trained clinicians at each performance site. CR will entail 30, 60-minute sessions administered two times a week (approximately 15 weeks). All participants will continue to receive recovery oriented therapeutic activities. Participants will be scheduled to repeat behavioral assessments at Time 2 (post-treatment) and Time 3 (follow-up) with a research team member who is blind to treatment group. The EAP- group receiving Brain Basics will also repeat EEG paradigms at Time 2 to explore 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. Mediation analysis will examine whether gains in cognition (verbal learning) mediate the gains in EAP and functioning. This will inform our understanding of EAP as the therapeutic change mechanism for about half of CR participants and confirm that EAP training need not be given to those CR participants with baseline intact EAP.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date May 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria: - A primary DSM-5 diagnosis of schizophrenia or schizoaffective disorder - Psychiatrically stable, as defined by no changes in psychotropic medication or psychiatric hospitalization in the most recent 21 days - English-speaking Exclusion Criteria: - Indications of Intellectual Disability as documented in medical history or measured by < 70 premorbid Full Scale IQ - Documented auditory disorder or known visual impairment; presence of neurological conditions that are impacting brain and cognitive functioning - Unremitted substance dependence within the past six months - Participation in cognitive remediation in the 24 months prior

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Pibly Residential Programs Inc. Bronx New York
United States Heights Hill Clinic Brooklyn New York
United States Institute for Community Living Brooklyn New York
United States Mapleton Mental Health Services Brooklyn New York
United States Williamsburg Clinic Brooklyn New York
United States Manhattan Psychiatric Center 125th Street Clinic New York New York
United States The Bridge, Inc. New York New York
United States Rockland Psychiatric Center Orangeburg New York
United States Laurel House Stamford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Columbia University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Verbal Learning Verbal Learning is assessed with the MATRICS Consensus Cognitive Battery Verbal Learning Domain score. The primary outcome will be change in this score from pre to post treatment such that a higher value represents a better outcome. 15 weeks
Secondary Change in Functional Capacity Functional Capacity is assessed with the UCSD Performance Based Skills Assessment, Brief version. The secondary outcome will be change in the total score from pre to post treatment such that a higher value represents a better outcome. 15 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A