Clinical trial NCT04554121: Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
Official title: Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Cognitive Remediation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-18
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Verbal Learning
timeFrame: 15 weeks
Secondary outcomes:
measure: Change in Functional Capacity
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Laurel House
state: Connecticut
city: Bronx
country: United States
facility: Pibly Residential Programs Inc.
state: New York
city: Brooklyn
country: United States
facility: Williamsburg Clinic
state: New York
city: Brooklyn
country: United States
facility: Institute for Community Living
state: New York
city: Brooklyn
country: United States
facility: Heights Hill Clinic
state: New York
city: Brooklyn
country: United States
facility: Mapleton Mental Health Services
state: New York
city: New York
country: United States
facility: The Bridge, Inc.
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center 125th Street Clinic
state: New York
city: Orangeburg
country: United States
facility: Rockland Psychiatric Center
state: New York
Study officials:
affiliation: Columbia University
name: Alice Medalia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: