Comparing Cognitive Remediation Approaches for Schizophrenia

Comparing Cognitive Remediation Approaches for Schizophrenia

Sponsors

Lead sponsor: Wesleyan University

Collaborator: Hartford Hospital
National Institute of Mental Health (NIMH)

Source Wesleyan University
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.

Overall Status Not yet recruiting
Start Date November 2019
Completion Date July 2022
Primary Completion Date July 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Matrics Consensus Cognitive Battery score (MCCB composite score) Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
UCSD Performance-Based Skills Assessment Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Quality of Life Scale Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Enrollment 135
Condition
Intervention

Intervention type: Behavioral

Intervention name: Cognitive Remediation

Description: Cognitive remediation (CR) is a behavioral treatment designed to address neurocognitive deficits through task practice and/or strategy acquisition.

Intervention type: Behavioral

Intervention name: Computer Games

Description: Sham placebo treatment

Arm group label: Computer Games

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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Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Matthew M Kurtz, PhD

Phone: 860-685-2072

Email: [email protected]

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Wesleyan University

Investigator full name: Matthew M. Kurtz

Investigator title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Restorative CR Intervention

Arm group type: Experimental

Description: The restorative remediation intervention will consist of a target of 50 hours (5 hours per week, 1 hour per day, over 3 months) of a sequence of computerized cognitive exercises designed to improve cognitive function through repeated drill-and-practice of exercises largely focused on attention, working memory and verbal episodic memory. Cognitive deficits will be directly targeted by these exercises. Exercises will be started at individually determined levels of difficulty at which each client will be successful, e.g., 80% accuracy. Task difficulty will be increased as performance improves.

Arm group label: Strategy CR Intervention

Arm group type: Experimental

Description: Participants in this intervention will be treated for 24 hours (2 hours per week, one day per week over 3 months) with Compensatory Cognitive Training (CCT). The therapy targets four cognitive domains: (a) prospective memory, (b) attention and vigilance, (c) learning and memory, and (d) executive function. The program is a group-based intervention that teaches strategies via interactive, game-like activities to maintain interest and enhance motivation and engagement.

Arm group label: Computer Games

Arm group type: Placebo Comparator

Description: Three months of 1-hour, 5-times per week, client-selected computer games.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov