PRIME App + Cognitive Training for Psychosis
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen BySophia Vinogradov, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a mobile app designed to improve thinking skills and motivation in people with early psychosis. The app offers mental exercises and social skills training to help users enhance their cognitive abilities and motivation. The goal is to see if this approach can lead to better long-term outcomes compared to standard treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must have been on stable doses of psychiatric medication for at least one month before joining the study.
What data supports the effectiveness of the treatment PRIME App + Cognitive Training for Psychosis?
Research shows that computer-based cognitive training can improve cognitive deficits in psychosis, and the PRIME app, which includes motivational coaching and peer support, may enhance motivation and social functioning. Additionally, cognitive remediation therapy has been shown to improve cognition and aid recovery in people with psychosis.
12345Is the PRIME App + Cognitive Training for Psychosis safe for humans?
The studies reviewed do not report any specific safety concerns related to the use of the PRIME App combined with cognitive training for psychosis, suggesting it is generally safe for human use.
12567How is the PRIME App + Cognitive Training treatment for psychosis different from other treatments?
The PRIME App + Cognitive Training treatment is unique because it combines web-based cognitive and social cognitive training with a smartphone app that provides personalized motivational coaching and peer support, making it more accessible and engaging compared to traditional treatments.
12389Eligibility Criteria
This trial is for individuals with early psychosis who are part of a measurement-based care study, have an IQ above 70, access to a smartphone or mobile device, and are in good general health. They should be clinically stable as outpatients for at least one month and on steady psychiatric medication doses.Exclusion Criteria
I cannot make medical decisions for myself and my guardian cannot consent to research on my behalf.
Participant Groups
The study tests a 12-week mobile intervention program using the PRIME app aimed at improving cognition and motivation in early psychosis patients. It compares clinical progress over 18 months between those receiving the intervention and those who do not.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME)Experimental Treatment3 Interventions
The Mobile Intervention. 20 hours of training consisting of 10 hours of cognitive training exercises plus 10 hours of social cognitive training exercises will be delivered over the course of 12 weeks in addition to PRIME. Participants may choose to complete study activities in person at their coordinated specialty care program or may choose to complete study activities remotely.
Group II: Treatment as UsualActive Control1 Intervention
Participants will be treated as usual and will not complete cognitive training or use the Personalized Real-Time Motivational Enhancement App. Participants may choose to complete study activities in person at their coordinated specialty care program or may choose to complete study activities remotely.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
Hennepin HealthcareMinneapolis, MN
Human Development CenterDuluth, MN
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. [2023]Impairments in cognition and motivation are core features of psychosis and strong predictors of social and occupational functioning. Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, barriers include access and adherence to cognitive training exercises. Limited evidence-based methods have been established to enhance motivated behavior. In this study, we tested the effects of web-based targeted cognitive and social cognitive training (TCT) delivered in conjunction with an innovative digital smartphone app called Personalized Real-Time Intervention for Motivational Enhancement (PRIME). The PRIME app provides users with a motivational coach to set personalized goals and secure social networking for peer support.
Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. [2023]Cognitive remediation (CR) improves cognition and aids recovery in people with psychosis. An active therapist provides increased benefit, but CR training for therapists is not routinely available, so CR has limited scalability. This study describes the development and evaluation of the first online CR therapist training programme.
Effects of a Metacognitive Smartphone Intervention With Weekly Mentoring Sessions for Individuals With Schizophrenia: A Quasi-Experimental Study. [2023]Application (app)-based interventions using smartphones could provide effective alternatives to traditional treatment programs during and beyond the coronavirus disease 2019 pandemic. The current quasi-experimental study with a non-equivalent comparison group tested the effects of a smartphone app-based metacognitive intervention program with weekly mentoring sessions on the meta-cognitive beliefs, psychotic symptoms, and social functioning of individuals with schizophrenia from community psychosocial rehabilitation centers. The study was conducted with 20 participants with severe psychotic symptoms and low social functioning and 24 participants with relatively light psychotic symptoms and good social functioning as a comparison group. For the experimental group, the app-based intervention was combined with weekly contact mentoring sessions over 10 weeks. The comparison group received only the app-based intervention over 10 weekly sessions. No differences were observed between groups' total scores; however, the experimental group showed a tendency toward improved psychotic symptoms and social functioning over time, unlike the comparison group. These findings provide an empirical basis for managing schizophrenia symptoms with smartphone apps. [Journal of Psychosocial Nursing and Mental Health Services, 61(2), 27-37.].
Current trends in the empirical study of cognitive remediation for schizophrenia. [2019]Cognitive remediation (CR) for schizophrenia is a learning-based behavioural skills training intervention designed to enhance neuro and (or) social cognitive skills, with the ultimate goal of generalization to improve psychosocial outcomes. This review summarizes conceptual approaches to CR for schizophrenia and the evidence for efficacy in clinical research settings. Four issues are at the forefront of ongoing research: the identification of techniques that produce the largest cognitive change, delineation of techniques that enhance transfer of cognitive skills to functional skills, the identification of CR methods that can be personalized to meet the specific cognitive and functional needs of each individual, and, all the while, ensuring that when CR methods are developed in a research setting, they remain scalable for delivery in the larger clinical community. In response to these issues, 3 prominent research trends have emerged: the rise of a new generation of computerized restorative cognitive training, the integration of CR with skills training to promote generalization, and the application of techniques to enhance motivation and learning during CR. As data on the neural basis of learning in people with schizophrenia become available, new technologies that harness the ability of the brain to make sustainable, functional changes may be integrated within a therapeutic context that promotes a personalized approach to learning. The development of transportable and scalable methods of CR that maximize the ability of people with schizophrenia to improve cognition will help them achieve personal goals for recovery.
Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. [2019]Despite effective pharmacotherapy for positive symptoms of psychosis, cognitive deficits emerge early and are persistent. Efficacy studies have demonstrated cognitive training can produce improvement in cognition, symptoms, and functional outcomes for psychosis. A chart review of seventy-one first episode psychosis patients in a cognitive training program was designed to determine feasibility and effectiveness of the program in a non-research clinic setting. Cognitive testing data, symptom change, and re-hospitalization data were reviewed. The MATRICS Consensus Cognitive Battery (MCCB) was used to measure processing speed, attention, memory, verbal learning, visual learning, problem solving, and social cognition. Improvements in global cognition were found (p
The impact of social cognition training on recovery from psychosis. [2018]Social cognition training is an emerging intervention, which aims to ameliorate impairment in social interaction and improve functional outcomes in persons with a psychosis. This article reviews the research conducted on the impact of this intervention published in English language journals over the past 2 years.
Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. [2022]Deficits in cognition, social cognition, and motivation are significant predictors of poor functional outcomes in schizophrenia. Evidence of durable benefit following social cognitive training is limited. We previously reported the effects of 70 h of targeted cognitive training supplemented with social cognitive exercises (TCT + SCT) verses targeted cognitive training alone (TCT). Here, we report the effects six months after training.
Independent Computerized Cognitive Remediation for Psychosis: An Investigation of Patient Experiences. [2019]Cognitive remediation (CR) training improves cognition and functioning in patients with psychosis. To date, however, few studies have investigated CR from a subjective patient perspective. We recently conducted a randomized control trial demonstrating the effectiveness of a new, low therapist support, computer-based training program. This study aims to assess the service user experience of this program. Twenty CR completers with psychosis were interviewed using both rated and open-ended questions. Thematic analysis identified three broad themes: a) benefits of doing CR, b) costs of doing CR, and c) experience of doing CR. Positive experiences of therapy participation included improved cognition, improved positive self-regard, a development of life skills, and a transfer of benefits to everyday life. Negative experiences included therapy being difficult and tiring, leading to frustration and anxiety. These findings demonstrate the feasibility of low therapist support CR and point to variables that might impact therapy adherence.
Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology. [2021]Cognitive impairment has adverse impact on the social and role functions of those at clinical high risk for psychosis and it has become an important target for intervention. Mobile health applications are user-friendly, real-time, personalized and portable in administering cognitive training and have promising application prospects in the field of mental health.