Trial Summary
What is the purpose of this trial?
The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. We will recruit participants who are receiving care for early psychosis from clinics across the United States. We will compare outcomes from participants who receive treatment at coordinated specialty care (CSC) early psychosis clinics to those that receive standard community care. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have had significant changes to medications recently, suggesting that stable medication use is preferred.
What data supports the effectiveness of the treatment Cognitive and Social Cognitive Training, Cognitive Training, Social Cognitive Training, Mobile Cognitive Training, Early Psychosis Coordinated Specialty Care, Coordinated Specialty Care (CSC) for Early Psychosis, Early Psychosis Intervention (EPI), Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App, Personalized Real-Time Intervention for Motivational Enhancement App, PRIME App?
Research shows that cognitive training and remediation can improve cognitive functions like memory and executive function in early psychosis, and the PRIME app helps enhance motivation by providing personalized goals and peer support. These interventions, when combined, have shown promise in improving social and occupational functioning in individuals with early psychosis.12345
Is the Cognitive + Motivational Enhancement for Early Psychosis treatment safe for humans?
How is the Cognitive and Social Cognitive Training with PRIME App treatment different from other treatments for early psychosis?
Research Team
Sophia Vinogradov, MD
Principal Investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
Piper Meyer-Kalos, PhD
Principal Investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
Eligibility Criteria
This trial is for individuals aged 18-40 with early psychosis or related conditions, enrolled in a specialty care clinic. They must be stable (no recent hospitalization or active suicidal thoughts), have access to a smartphone and computer, speak English fluently, and have an IQ above 70.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 12-week mobile intervention program targeting cognitive functioning and motivated behavior
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up assessments at 6 and 12 months post-training
Treatment Details
Interventions
- Cognitive and Social Cognitive Training (Behavioral Intervention)
- Early Psychosis Coordinated Specialty Care (Other)
- Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator