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Eligibility
for people ages 18–60
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The purpose of this study is to use remote methods and scalable interactive neurotechnology to generate important data on the potential for remote targeted cognitive treatment in people with schizophrenia. The investigators will perform a double-blind randomized control trial in 120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40 hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours per week), delivered with an innovative digital application which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per week over 12 weeks, delivered with a standard commercial goal-setting app, "Daily Goals".

Details

A double-blind randomized control trial in schizophrenia, comparing: 1) The treatment condition-- 40 hours of cognitive training over 12 weeks (~3.5 hours per week) in a structured program of 10 hours of social cognition exercises followed by 30 hours of auditory processing exercises, combined with the Personalized Real-time Intervention for Motivational Enhancement (PRIME) coaching app; or 2) The active control condition-- free-choice access to a broad range of cognitive exercises across various domains, encouraged at 3.5 hours per week over 12 weeks, combined with the commercial Daily Goals app. The investigators will recruit 204 schizophrenia subjects to be stratified by age (18-40, 40-60) and education (<14 years,>14 years) and randomly assigned to one of the two conditions. Subjects and assessors will be blind to group assignment. The investigators will perform both per protocol and intent-to-treat analyses.

Keywords

Treatment Active Control Schizophrenia

Eligibility

For people ages 18–60

  1. Eligible participants will have a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I Disorders (SCID-I) confirmed clinical diagnosis of schizophrenia or schizoaffective disorder.
  2. Eligible participants must be in good general physical health.
  3. Eligible participants must be between the ages of 18 and 60 years old.
  4. Eligible participants must speak English as their first language.
  5. Eligible participants must have no neurological disorder.
  6. Eligible participants must have no psychiatric hospitalizations for at least 3 months prior to study participation.
  7. Eligible participants must be on stable doses of psychiatric medications for at least one month prior to participation.

Subjects will be excluded if:

  1. There is a history of substance dependence in the past 12 months determined by DSM criteria.
  2. They do not meet any of the aforementioned exclusion criteria.

Locations

  • University of Minnesota, Dept of Psychiatry accepting new patients
    Minneapolis, Minnesota, 55454, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota - Clinical and Translational Science Institute
ID
NCT02782442
Study Type
Interventional
Last Updated
January 1, 2017
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