Cognitive Training Delivered Remotely to Individuals With Psychosis

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).