PRIME App + Cognitive Training for Psychosis

Not currently recruiting at 2 trial locations

Overseen By Marielle Demarais, PhD, LP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Legal commitment, Cognitive training, Neurological disorder, Substance abuse, Suicidal behavior, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week mobile program can enhance thinking skills and motivation in individuals with early psychosis, a mental health condition where people might experience hallucinations or unusual thoughts. Participants will either use the app, which provides cognitive training and motivational support, or continue with their usual care. The trial will compare outcomes over 18 months to assess the app's effectiveness. Ideal participants are those already in a specific care program for early psychosis, stable on medication, and with access to a smartphone for app use. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve early psychosis care.

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 prior data suggests that this mobile intervention program is safe for individuals with early psychosis?

Research has shown that programs designed to improve thinking skills in people with psychosis can be helpful. Participants in studies have well-received these programs, which often use computers. Although keeping people engaged can be challenging, no major negative effects have been reported.

Regarding the PRIME app, research suggests it is safe and easy to use. The app includes a motivational coach and offers ways to connect with others for support. In studies, participants found it helpful for improving mood and motivation, with no major safety concerns.

Overall, previous research has demonstrated that both cognitive training and the PRIME app are safe. Participants generally responded well to these treatments, and no serious side effects were reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRIME App + Cognitive Training for psychosis because it combines cognitive and social cognitive training with a personalized real-time motivational enhancement app. Unlike traditional treatment options that often rely on medication or standard therapy sessions, this approach offers a digital, interactive platform that can be accessed remotely, giving participants flexibility and autonomy. The integration of real-time motivational feedback is a novel feature that could enhance engagement and outcomes by providing immediate support and encouragement tailored to individual progress and needs.

What evidence suggests that this mobile intervention program is effective for early psychosis?

Research has shown that training programs can improve thinking skills in people with psychosis, enhancing mental abilities like memory and problem-solving. In this trial, one group of participants will receive Cognitive and Social Cognitive Training combined with the Personalized Real-Time Motivational Enhancement (PRIME) app. The PRIME app has proven effective in boosting motivation and mood in young people with schizophrenia-related disorders. Evidence suggests that PRIME is both practical and well-received as a mobile tool. Together, these methods aim to address thinking challenges and increase motivation in early psychosis. ^{2 3 6 7 8}

Who Is on the Research Team?

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been stable and not hospitalized for at least a month and on a steady dose of psychiatric medication (or no medication) for the same period.

Has access to a smartphone or other mobile device to use the PRIME app

Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)

Exclusion Criteria

Participated in significant cognitive training programs within the last three years

I cannot make medical decisions for myself and my guardian cannot consent to research on my behalf.

Risk of suicidal behavior, as indicated by the clinically obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as: Active suicidal ideation at screening or baseline, or Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week mobile intervention program targeting cognitive functioning and motivated behavior

12 weeks

Participants may choose to complete study activities in person or remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Assessments at baseline, 6 months, 12 months, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive and Social Cognitive Training
• Personalized Real-Time Motivational Enhancement (PRIME) App

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME) Experimental Treatment 3 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study involved 100 participants with psychosis spectrum disorders who underwent 30 hours of targeted cognitive training combined with a motivational app (PRIME), showing significant improvements in global cognition and attention, as well as motivation and symptoms of depression.

Participants using the TCT+PRIME intervention demonstrated greater gains in emotion recognition compared to those using a computer games control, indicating that this combined approach may be more effective in enhancing cognitive and motivational outcomes in individuals with psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. Fisher, M., Etter, K., Murray, A., et al.[2023]

Social cognition training, which includes targeted, broad-based, and comprehensive programs, shows promise in improving social interactions for individuals with psychosis, with targeted programs being the most effective.

While there is some evidence that Theory of Mind (ToM) can be improved through these interventions, other areas like facial affect recognition and attributional bias show less potential for change, indicating a need for further research to enhance the effectiveness of these training strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of social cognition training on recovery from psychosis. Henderson, AR.[2018]

Cognitive training for 71 first episode psychosis patients showed significant improvements in global cognition, particularly in working memory and processing speed, indicating its potential effectiveness in enhancing cognitive function.

Patients without comorbid diagnoses who participated in cognitive training had lower re-hospitalization rates compared to those in other treatment programs, suggesting that cognitive training may improve long-term outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. Murray, A., Svendahl, K., Lee, S., et al.[2019]

A study involving 111 participants with schizophrenia spectrum disorders found that both targeted cognitive training with social cognitive exercises (TCT + SCT) and targeted cognitive training alone (TCT) led to lasting improvements in cognition, symptoms, and functional capacity six months after the intervention.

Participants who received TCT + SCT showed greater and more enduring benefits in prosody identification and reward processing compared to those who only received TCT, suggesting that integrating social cognitive training can enhance functional outcomes in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. Miley, K., Fisher, M., Nahum, M., et al.[2022]

The first online cognitive remediation (CR) therapist training program was developed and evaluated, showing that it is feasible and acceptable for mental health professionals, with most participants completing the training successfully.

The training significantly improved knowledge among clinicians, particularly benefiting those with less experience, indicating its potential to enhance the delivery of CR in treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. Taylor, R., Crowther, A., Tinch-Taylor, R., et al.[2023]

A randomized control trial with 20 participants showed that a low therapist support, computer-based cognitive remediation (CR) program significantly improved cognition and functioning in patients with psychosis, highlighting its effectiveness.

Participants reported both positive outcomes, such as improved cognitive skills and self-esteem, and negative experiences, like frustration and anxiety, indicating that while CR is beneficial, it can also be challenging and may affect adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent Computerized Cognitive Remediation for Psychosis: An Investigation of Patient Experiences. Hargreaves, A., Daly-Ryan, N., Dillon, R., et al.[2019]

A study involving 80 individuals at clinical high risk for psychosis showed that using a mobile app for cognitive training significantly improved attention and vigilance over three months compared to a control group.

The improvement in cognitive function was linked to the amount of time spent on training, indicating that mobile health applications can effectively enhance cognitive abilities in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology. Li, H., Yang, S., Chi, H., et al.[2021]

Cognitive remediation (CR) for schizophrenia aims to improve cognitive and social skills, with ongoing research focusing on techniques that maximize cognitive change and ensure these skills translate into real-life functional improvements.

Emerging trends in CR include the use of computerized training, integration with skills training for better generalization, and methods to enhance motivation, all aimed at creating personalized and scalable interventions for individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in the empirical study of cognitive remediation for schizophrenia. Saperstein, AM., Kurtz, MM.[2019]

A quasi-experimental study involving 44 participants with schizophrenia tested a smartphone app-based metacognitive intervention combined with weekly mentoring sessions over 10 weeks, showing a tendency for improved psychotic symptoms and social functioning in the experimental group.

While no significant differences were found in total scores between the experimental group and the comparison group, the results suggest that app-based interventions could be a valuable tool for managing schizophrenia symptoms, especially when combined with mentoring support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Metacognitive Smartphone Intervention With Weekly Mentoring Sessions for Individuals With Schizophrenia: A Quasi-Experimental Study. Han, M., Lee, K., Kim, M., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S092099642400505X

Does metacognitive training for psychosis (MCT) improve ... Metacognitive training for psychosis (MCT) offers benefits for addressing hallmark deficits/symptoms in schizophrenia spectrum disorders including reductions in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37955951/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, ...

3. jmir.org jmir.org/2023/1/e48634/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02340559

Effectiveness of Meta-Cognitive Training (EMC) in People ... Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution. ... Secondary outcomes will change in other assessments of social ...

5. nature.com nature.com/articles/s41398-025-03344-0

Metacognitive training for psychosis (MCT): a systematic ... Metacognitive training for psychosis (MCT): a systematic meta-review of its effectiveness · Introduction · Methods · Results · Discussion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10682932/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, barriers include ...

7. cotipplab.umn.edu cotipplab.umn.edu/cognitive-training-delivered-remotely-individuals-psychosis-roam

Cognitive Training Delivered Remotely to Individuals with ... The objective of this study is to assess the utility of remote mobile interventions for psychosis and their impact on behavior, cognition, and functioning. +.

8. cognitivetrainingdata.org cognitivetrainingdata.org/studies-cognitive-training-benefits/

Published Papers “The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial.” Journal of ...