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Behavioral Intervention

Cognitive + Motivational Enhancement for Early Psychosis

N/A
Recruiting
Led By Piper Meyer-Kalos, PhD
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 assess a mobile intervention program to target cognitive functioning & motivated behavior for early psychosis. Participants will be recruited from early psychosis CSC programs in the US & tested remotely at home on their own devices.

Who is the study for?
This trial is for individuals aged 18-40 with early psychosis or related conditions, enrolled in a specialty care clinic. They must be stable (no recent hospitalization or active suicidal thoughts), have access to a smartphone and computer, speak English fluently, and have an IQ above 70.Check my eligibility
What is being tested?
The study tests a mobile intervention program targeting cognition and motivation over 12 weeks against usual treatment. Participants will use the PRIME App and cognitive training exercises at home, with follow-ups at 6 and 12 months post-training.See study design
What are the potential side effects?
Since this trial involves cognitive training and app-based interventions rather than medication, typical medical side effects are not expected. However, participants may experience fatigue or stress from regular engagement with the exercises.

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 in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Drive Score
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Reward Responsiveness Score
+8 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 EnhancementExperimental 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. Participants will also engage in the PRIME app on a smart phone and will receive personalized support from a motivation enhancement coach.
Group II: Treatment as UsualActive Control1 Intervention
Participants will be treated as usual in their early psychosis CSC program and will not complete cognitive training or use the Personalized Real-Time Motivational Enhancement App.

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,801 Previous Clinical Trials
2,661,124 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,389 Previous Clinical Trials
1,552,887 Total Patients Enrolled
Piper Meyer-Kalos, PhDPrincipal InvestigatorUniversity of Minnesota Department of Psychiatry and Behavioral Sciences
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Cognitive and Social Cognitive Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05877716 — N/A
Cognitive and Social Cognitive Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05877716 — N/A
Major Depressive Disorder Clinical Trial 2023: Cognitive and Social Cognitive Training Highlights & Side Effects. Trial Name: NCT05877716 — N/A
Major Depressive Disorder Research Study Groups: Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement, Treatment as Usual
~96 spots leftby Jul 2025
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