Comparing Cognitive Remediation Approaches for Schizophrenia

Schizophrenia Clinical Trial

Official title:

Comparing Cognitive Remediation Approaches for Schizophrenia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04123223
• Other study ID #: 1R15MH117676-01A1
• Secondary ID: 1R15MH117676-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: Wesleyan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 135
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive Remediation
Cognitive remediation (CR) is a behavioral treatment designed to address neurocognitive deficits through task practice and/or strategy acquisition.
• Computer Games
Sham placebo treatment

Locations

Country	Name	City	State
United States	Institute of Living	Hartford	Connecticut
United States	River Valley Services	Middletown	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Wesleyan University	Hartford Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Matrics Consensus Cognitive Battery score (MCCB composite score)	The MCCB includes state-of-the-art cognitive probes selected by 74 experts using the RAND panel method. The battery has strong reliability in schizophrenia and includes multiple forms for many subtests to help control for practice effects. Summary T-scores range from 20 to 80 with higher scores indicating better cognitive performance.	Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Primary	UCSD Performance-Based Skills Assessment	This standardized performance-based instrument of everyday function, with evidence of reliability and validity in schizophrenia samples, provides information regarding patients' ability to manage information/planning, finance, communications, mobility and household management in role-play situations.Scores range from 0-20 with higher scores indicating better functioning.	Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Primary	Quality of Life Scale	A 21-item scale commonly used as a measure of psychosocial functioning in schizophrenia. The Quality-of-Life Scale balances subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning.Scores range from 0-42 with higher scores indicating better functioning.	Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.