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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will enroll participants from a larger study that is investigating different aspects of care for people with early psychosis. The current study will focus on a 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior. The investigators will compare the clinical trajectories of those who receive the intervention to those who do not over 18 months.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
COMPASS-10
Other outcome measures
BrainHQ Cognitive Training Performance Data
Tolerability of BrainHQ Cognitive Training & PRIME

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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,342 Total Patients Enrolled
11 Trials studying Psychosis
1,225 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,356 Total Patients Enrolled
46 Trials studying Psychosis
10,319 Patients Enrolled for Psychosis
Sophia Vinogradov, MDPrincipal InvestigatorUniversity of Minnesota Department of Psychiatry and Behavioral Sciences
13 Previous Clinical Trials
3,050 Total Patients Enrolled
8 Trials studying Psychosis
1,300 Patients Enrolled for Psychosis

Media Library

Cognitive and Social Cognitive Training Clinical Trial Eligibility Overview. Trial Name: NCT05112432 — N/A
Psychosis Research Study Groups: Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME), Treatment as Usual
Psychosis Clinical Trial 2023: Cognitive and Social Cognitive Training Highlights & Side Effects. Trial Name: NCT05112432 — N/A
Cognitive and Social Cognitive Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112432 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor allow individuals over the age of sixty to participate?

"This clinical trial is restricted to individuals between 15-40 years of age. For reference, there are 117 trials recruiting minors and 263 studies looking for elderly volunteers."

Answered by AI

Are there any openings remaining for eligible participants in this trial?

"As per the online clinicaltrials.gov records, this research is actively enrolling volunteers. This medical trial was first posted on August 12th 2021 and was last modified on June 8th 2022."

Answered by AI

What is the sample size of people taking part in this investigation?

"That is right. Clinicaltrials.gov specifies that this research effort, which was brought to light on August 12th 2021, continues to look for participants. The study requires 400 individuals from 3 medical sites in total."

Answered by AI

Is participation in this trial open to new members?

"Candidates aged 15 to 40 with a psychosis diagnosis may seek admission into this clinical trial, for which 400 participants are required."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
EPI-MINN: Targeting Cognition and Motivation
2021. "EPI-MINN: Targeting Cognition and Motivation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112432.
~128 spots leftby Jul 2025
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