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"Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)

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ClinicalTrials.gov Identifier: NCT02782442
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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".

Condition or disease Intervention/treatment Phase
Treatment Active Control Schizophrenia Psychosis Schizoaffective Disorder Behavioral: Structured Cognitive Training & PRIME Behavioral: Computer Games Control & PRIME Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Cognitive Training Delivered Remotely to Individuals With Psychosis
Study Start Date : September 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Structured Cognitive Training & PRIME
Structured cognitive training consists of social cognition and auditory exercises.
Behavioral: Structured Cognitive Training & PRIME
The treatment condition-- 40 hours of CT 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 PRIME coaching application

Active Comparator: Computer Games Control & PRIME
Computer games control condition comes in the official PositScience wrapper.
Behavioral: Computer Games Control & PRIME
Computer games control condition which comes in the official PositScience wrapper. 40 hours of games over 12 weeks (~3.5 hours per week). combined with the personalized PRIME coaching application.




Primary Outcome Measures :
  1. Measures of response time in Sensorimotor Processing Speed as measured by the Penn Computerized Neurocognitive Battery (CNB). [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Motivated behavior as measure through the Behavioral Approach System and Behavioral Inhibition System (BIS-BAS) [ Time Frame: up to 24 months ]
  2. Social functioning as measured through the Abbreviated Quality of Life Scale [ Time Frame: up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782442


Contacts
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Contact: Neelu Ghiasi 612-625-1586 roam@umn.edu
Contact: Ariel Currie (612) 626-7261 roam@umn.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94117
Contact: Neelu Ghiasi    612-625-1586    roam@umn.edu   
United States, Minnesota
University of Minnesota, Dept of Psychiatry Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Neelu Ghiasi    612-625-1586    roam@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of California, San Francisco
Investigators
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Principal Investigator: Sophia Vinogradov, MD University of Minnesota Department of Psychiatry

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02782442     History of Changes
Other Study ID Numbers: Stanley 2.0
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
cognitive training

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders