NCT02105779

Brief Summary

The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2016

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

6.4 years

First QC Date

March 11, 2014

Last Update Submit

April 3, 2019

Conditions

SchizophreniaPsychosis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Social Cognition at 6 months

    Social functioning scale

    Baseline (Intake)/6 months follow-up after trianing completion

Study Arms (2)

Targeted Cognitive Training

EXPERIMENTAL

40 hours of BFP auditory training

Other: Targeted Cognitive Training

Social Cognitive Training

EXPERIMENTAL

40 hours of auditory training and 10 hours social exercises

Other: Social Cognitive Training

Interventions

Targeted Cognitive TrainingOTHER

At present, the 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 (30 hours), and a Visual Module (30 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.

Targeted Cognitive Training
Social Cognitive TrainingOTHER

We developed a systematic approach to basic training in facial emotion identification and discrimination and simple social perception and theory of mind tasks using components drawn from three commercially available software packages: the MicroExpressions Training Tool and The Subtle Expressions Training Tool (METT and SETT), plus the MindReading program. Training begins with simple emotion identification tasks, and slowly progressed to more difficult tasks that required subjects to discriminate between two subtle emotion expressions, and to correctly interpret the emotional significance of brief social scenes. A total of 10 hours of training occurred over 8 weeks.

Social Cognitive Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of schizophrenia or schizoaffective disorder
  • Between 18-65 years of age
  • Clinically stable
  • Fluent in English

You may not qualify if:

  • Recent hospitalization, in the past 3 months
  • History of traumatic brain injury
  • Neurological disorders
  • Inability to participate in the study soberly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Veterans Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Fisher M, Nahum M, Howard E, Rowlands A, Brandrett B, Kermott A, Woolley J, Vinogradov S. Supplementing intensive targeted computerized cognitive training with social cognitive exercises for people with schizophrenia: An interim report. Psychiatr Rehabil J. 2017 Mar;40(1):21-32. doi: 10.1037/prj0000244.

    PMID: 28368179DERIVED

  • Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.

    PMID: 27617637DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental 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, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

April 7, 2014

Study Start

December 1, 2009

Primary Completion

May 1, 2016

Study Completion

July 26, 2016

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

US(1)