What side effects are associated with this type of intervention?

Common treatments for psychosis, such as antipsychotic medications, can cause side effects including weight gain, sedation, and metabolic changes. Cognitive-behavioral therapy (CBT) and mobile interventions, which aim to enhance cognitive functioning and motivated behavior, generally have fewer side effects but may face challenges with patient adherence and engagement. Repetitive transcranial magnetic stimulation (rTMS) may cause headaches and discomfort at the stimulation site.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of psychosis, including drugs like paliperidone palmitate and aripiprazole, which are used to manage symptoms in schizophrenia. Paliperidone palmitate, for instance, is available in a long-acting injectable form that helps in maintaining symptom control. Additionally, neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been explored for their potential to reduce negative symptoms and improve cognitive functioning in schizophrenia, although results have been mixed. While these treatments primarily focus on symptom management, ongoing research, including mobile intervention programs, aims to enhance cognitive functioning and motivated behavior in patients with early psychosis.

What other types of research exist?

Promising alternatives to a 12-week mobile intervention program for psychosis patients include: 1) Cognitive-behavioral therapy (CBT) delivered through smartphone apps, which has shown efficacy in improving cognitive functioning and motivated behavior. 2) Telemedicine platforms like the MONEO platform, which have been effective in managing clinical conditions in schizophrenia patients. 3) Text messaging relapse prevention programs, which provide daily monitoring and support to prevent symptom relapse. 4) Coordinated specialty care programs that offer comprehensive services including psychotherapy, medication management, and psychoeducation, tailored to early psychosis patients.

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PRIME App + Cognitive Training for Psychosis

N/A

Recruiting

Led By Sophia Vinogradov, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves cognitive training and motivational enhancement through an app, there may not be direct medical side effects; however, participants might experience frustration or stress if they find the tasks challenging.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change Penn Computerized Neuropsychological Testing System (Penn CNP) Scores

Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Drive Score

Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score

+9 more

Secondary study objectives

COMPASS-10

Other study objectives

BrainHQ Cognitive Training Performance Data

Tolerability of BrainHQ Cognitive Training & PRIME

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for psychosis, such as antipsychotic medications, cognitive-behavioral therapy (CBT), and mobile interventions, work through different mechanisms to improve patient outcomes. Antipsychotic medications primarily target dopamine receptors to reduce symptoms like hallucinations and delusions. CBT helps patients by addressing distorted thinking patterns and improving coping strategies. Mobile interventions, like the 12-week program, focus on enhancing cognitive functioning and motivated behavior through structured activities and goal-setting. These treatments are crucial for psychosis patients as they not only alleviate symptoms but also improve overall functioning and quality of life, enabling better integration into society and pursuit of personal goals.

Focusing on recovery goals improves motivation in first-episode psychosis."Hitting" voices of schizophrenia patients may lastingly reduce persistent auditory hallucinations and their burden: 18-month outcome of a randomized controlled trial.