Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)

Summary

Primary study:

This study is a single-site, double-blind, randomized, controlled clinical trial to compare an evidence-based structured program of 30-35 hours of on-line cognitive and social cognitive training exercises performed over 16 weeks (\~2 hours per week), delivered with an innovative digital app which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, "PRIME" ; vs. 2) A control condition of computer games, encouraged at \~2 hours per week over 16 weeks, delivered with "PRIME".

Unblinded Cognitive Training Sub-Study:

Participants who were randomized to the computer games arm of the trial may be offered access to the active cognitive training at the end of their 6 month follow up appointments, if they still meet inclusion criteria.

PRIME Super Users Sub-Study:

Participants who have provided all follow up data to the initial study, including those who are currently enrolled in the Unblinded Cognitive Training sub-study, may be offered continued participation in the PRIME community as super-users.

Conditions

• Treatment
• Active Control
• Schizophrenia
• Psychosis
• Schizoaffective Disorder
• Psychotic Depression
• Psychotic Mood Disorders
• Psychotic Disorders
• Psychotic Episode
• Cognitive Impairment

Interventions

BEHAVIORAL

Structured Cognitive Training & PRIME

The treatment condition-- 30-35 hours of CT over 16 weeks (\~2 hours per week) is a structured program of 20 hours of auditory processing exercises followed by 10 hours of social cognition exercises, combined with the personalized PRIME coaching application

BEHAVIORAL

Computer Games Control & PRIME

Computer games control condition which comes in the official PositScience wrapper. 30-35 hours of games over 16 weeks (\~2 hours per week), combined with the personalized PRIME coaching application.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Sophia Vinogradov, MD · University of Minnesota Department of Psychiatry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2022-03-12

Completion

2022-03-12

Countries

• United States

Study Locations