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

No Placebo-Only Group

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.

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.

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 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 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 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 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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