Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
Condition: Treatment; Active Control; Schizophrenia; Psychosis; Schizoaffective Disorder; Psychotic Depression; Psychotic Mood Disorders; Psychotic Disorders; Psychotic Episode; Cognitive Impairment
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders; Affective Disorders, Psychotic
Study type: Interventional

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.
    

Detailed description: 
      Primary study:

      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 psychosis. We will perform a double-blind RCT in 120 participants with psychosis,
      comparing: 1) An evidence-based structured program of 30-35 hours of on-line cognitive and
      social cognitive training exercises (CT) 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" . Both conditions will be administered using personal smartphone devices and
      computers and all procedures will be conducted remotely, including on-line recruitment in
      locations all over the world. Using both per protocol and intent-to-treat analyses, we will
      determine clinical, cognitive, and functional effects after the intervention using
      operationalized assessments delivered remotely, and will determine their relationship to
      functional outcome measures at 6-month follow-up.

      Both the active condition and the control condition will be provided through identical web
      portals designed for the study at no charge by Brain HQ (Posit Science, Inc.). PRIME, the
      personalized motivation coaching and social networking app, has been designed and developed
      by co-investigator Dr. Schlosser, supported by UCSF and NIMH. We will recruit a total of 204
      subjects with psychosis to be stratified by age (18-40, 40-60) and education (< 14 years, >14
      years) and randomly assigned to one of the two conditions.

      Unblinded Cognitive Training Sub-Study:

      During the debrief, participants will be asked if they would like to continue participating
      in the study and receive active cognitive training. If the participant agrees, they will sign
      a new consent form which covers the details of the next portion of the study. The data from
      their 6 month follow up appointment will be counted as their baseline data to reduce
      participant burden. They will start immediately with cognitive training and will continue
      through the 6 month follow up appointments, as above. Additionally, participants who enter
      into this study may be offered simultaneous participation in the PRIME Super Users sub-study
      (see below).

      PRIME Super Users Sub-study:

      As a super-user, PRIME members are asked to take on a peer-mentorship role in the community
      and maintain a certain level of activity within the application. Before offering
      participation in the sub-study, the study team will perform a case review to determine if
      PRIME would be beneficial to the individual, that they appear able to fulfill the role of a
      peer mentor, that they are likely to be consistently active within the community, and they
      are able to adhere to the PRIME code of conduct. Participants will sign informed consent
      before rejoining the community.

      As super-users, participants will be asked to be active members within the community and to
      maintain activity of once a week, on average. Participants will be asked to notify study
      staff if they anticipate or experience any extended absences from the app for any reason so
      their access to the community will not be revoked. Super-users will participate in the
      community by making posts, sharing moments, and commenting on the posts of other community
      members (including ROAM participants, Super-Users, and coaches). They are encouraged to share
      stories from their experiences and offer advice to other users for making and achieving
      goals, dealing with symptoms, and improving quality of life.
    

Intervention name(s): Structured Cognitive Training & PRIME; Computer Games Control & PRIME
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Training; Motivation Enhancement