Clinical trial NCT04123223: Comparing Cognitive Remediation Approaches for Schizophrenia
Official title: Comparing Cognitive Remediation Approaches for Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Wesleyan University
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2019-10-10
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. The present project seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies.
Primary purpose: TREATMENT

Brief summary: This research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits and community function in schizophrenia to help inform best practices. The proposed study advances public health by developing and evaluating new behavioral techniques for improving psychosocial outcome in individuals diagnosed with schizophrenia.

Detailed description: Evidence over the past 30 years has revealed that 70-80% of individuals with schizophrenia exhibit marked neurocognitive deficits on measures of attention, learning and memory, problem-solving, language and sensory-motor skill. Particular significance has been attached to these deficits as their severity has been linked to impaired community function, social problem-solving and progress in psychosocial rehabilitation programs. Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. Meta-analyses have revealed that cognitive remediation is a validated approach to improving cognitive function in schizophrenia, however a lack of precision regarding the active elements of the intervention have prevented its recommendation as a standard treatment for the illness. The present three-year proposal seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies. Both programs have strong preliminary empirical support. One-hundred and thirty-five clients diagnosed with schizophrenia or schizoaffective disorder will be randomly assigned to one of three groups: a neuroplasticity-based, drill-and-practice program of computer-assisted cognitive training exercises designed to restore lost cognitive capacity; a manualized strategy training method for bypassing deficits in cognition, or a computer games control condition. Study measures, organized according to an experimental therapeutics approach, with targets distinguished from outcomes, will assess generalization of any observed training effects.

Eligibility criteria: Inclusion Criteria:

1. Meeting DSM-5 criteria for schizophrenia or schizoaffective disorder, presenting for intensive outpatient clinical care.
2. Stabilized on atypical antipsychotic medication for a minimum of 2 months prior to entry into the protocol.
3. A minimum of 2 months since discharge from last hospitalization.

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Exclusion Criteria:

1. Uncorrected auditory or visual impairment.
2. Mental retardation (Full Scale IQ\<70, as estimated by single word-reading from the WRAT and/or evidence of a history of services).
3. Traumatic brain injury with loss of consciousness for more than 10 minutes.
4. Presence or history of any neurologic illness.
5. Lack of proficiency in English
6. Criteria met for concurrent substance dependence,
7. Scoring within 1SD of healthy control performance (from published norms) on measures of visual vigilance, verbal learning, and working memory.

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Primary outcomes:
measure: Matrics Consensus Cognitive Battery score (MCCB composite score)
timeFrame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
measure: UCSD Performance-Based Skills Assessment
timeFrame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
measure: Quality of Life Scale
timeFrame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: Middletown
country: United States
facility: River Valley Services
state: Connecticut
Study officials:
References: