Community-Based Cognitive Training in Early Schizophrenia

NCT01973270 | Completed DMC

• 1 other identifier: R01MH102063-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. We will investigate the effects of web-based cognitive training exercises delivered on a portable laptop computer. The findings will provide us with valuable information on whether cognitive training can improve the cognition and functioning of young individuals early in the course of schizophrenia.

Conditions

Schizophrenia; Psychosis

Outcome Measures

Primary Outcomes (4)

• Neurocognition

  Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery \[MCCB\]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving \[BACS Tower of London\]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody \[Penn Prosody Identification, and theory of mind \[Faux Pas test.7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up.

  Baseline, Post-Training, 6 month Follow-up

• Functioning

  The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning.

  Baseline, Post-Training, 6 Month Follow-up

• Auditory Processing Speed

  Early target engagement is the degree to which an individual demonstrates initial performance improvement ("learning") upon exposure to training. Early target engagement will be measured by auditory processing speed during cognitive training exercises.

  Baseline, 10 hours of training

• Reward Sensitivity

  The Temporal Experience of Pleasure Scale (TEPS) will be used to assess reward sensitivity.

  Baseline

Secondary Outcomes (3)

• Functional Capacity

  Baseline, Post-Training, 6 Month Follow-up

• Social Functioning

  Baseline, Post-Training, 6 Month Follow-up

• Internalized Stigma

  Baseline, Post-Training, 6 Month Follow-up

Other Outcomes (1)

• Feasibility and Acceptability

  Post-Training (6 weeks)

Study Arms (3)

Targeted Cognitive Training - TCT

EXPERIMENTAL

Neuroadaptive cognitive training

Behavioral: Neuroadaptive cognitive training

General Cognitive Exercises (GCE)

EXPERIMENTAL

Neuroadaptive cognitive training

Behavioral: Neuroadaptive cognitive training

Treatment as Usual

NO INTERVENTION

Treatment as Usual

Interventions

Neuroadaptive cognitive training BEHAVIORAL

TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). \[Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.

General Cognitive Exercises (GCE); Targeted Cognitive Training - TCT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), Unspecified Schizophrenia Spectrum Disorder, Schizophrenia Spectrum Disorder, Specified, or schizophreniform disorder with onset of first psychotic episode within the last 2 years.
• Good general physical health
• Between 18 and 35 years of age
• Is fluent and proficient in the English language
• Currently enrolled in PREP/BEAM services
• Achieved clinical stability (e.g., outpatient status for at least 1 month before study entry)

You may not qualify if:

• Any neurological disorder
• If clinically significant substance abuse occurs that is impeding the subject's ability to participate fully during recruitment, assessment, or training, the subject will be dropped from the study.
• Being treated with benztropine, diphenhydramine, or high doses of clozapine (\>500 mg po qd) or olanzapine(to be determined on a case by case basis)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Prevention and Recovery in Early Psychosis (PREP) Program

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Sophia Vinogradov, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: October 31, 2013
• Study Start: December 1, 2013
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

US (1)