PRIME App + Cognitive Training for Psychosis

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Sophia Vinogradov, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 5 6 7}

How 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. ^{1 2 3 8 9}

Research Team

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Eligibility 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.

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of a Metacognitive Smartphone Intervention With Weekly Mentoring Sessions for Individuals With Schizophrenia: A Quasi-Experimental Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Current trends in the empirical study of cognitive remediation for schizophrenia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Independent Computerized Cognitive Remediation for Psychosis: An Investigation of Patient Experiences. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology. [2021]