Comparing Cognitive Remediation Approaches for Schizophrenia

NCT04123223 | Unknown DMC

• 1 other identifier: 1R15MH117676-01A1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (3)

Restorative CR Intervention

EXPERIMENTAL

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.

Behavioral: Cognitive Remediation

Strategy CR Intervention

EXPERIMENTAL

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.

Behavioral: Cognitive Remediation

Computer Games

PLACEBO COMPARATOR

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

Behavioral: Computer Games

Interventions

Cognitive Remediation BEHAVIORAL

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

Restorative CR Intervention; Strategy CR Intervention

Computer Games BEHAVIORAL

Sham placebo treatment

Computer Games

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wesleyan University: lead
• Hartford Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Institute of Living

Hartford, Connecticut, 06102, United States

Location

River Valley Services

Middletown, Connecticut, 06457, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 10, 2019
• Study Start: November 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

US (2)