EPI-MINN: Targeting Cognition and Motivation - National
2 other identifiers
interventional
200
1 country
1
Brief Summary
The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. We will recruit participants who are receiving care for early psychosis from clinics across the United States. We will compare outcomes from participants who receive treatment at coordinated specialty care (CSC) early psychosis clinics to those that receive standard community care. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 21, 2025
August 1, 2025
3.1 years
May 17, 2023
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Change in Test My Brain Scores
Test My Brain is reported as the total score on 4 cognitive domains. The Digit Symbol Matching ranges from 0 -300+, the Verbal Paired Associated ranges from 0 - 25, the Matrix Reasoning ranges from 0 - 35, and the Multiracial Face Emotion Identification Test ranges from 0 - 48. Test My Brain will be assessed at baseline, during pre-training, at 6 months, 12 months, and 18 months. Higher scores indicate higher cognitive function. Performance score is calculated based on accuracy and reaction speed.
18 months
Change in Dysfunctional Attitudes Scale - Defeatist Beliefs Subscale (DAS-DB) Score
DAS-DB is measured over 14 items with total scores ranging from 14-98, where higher scores indicate greater defeatist beliefs. DAS-DB will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Quality of Life Scale - Abbreviated
The quality of life scale contains 9 items rated from 0 to 6, with higher scores indicating increased functioning/decreased symptom severity. Outcome is reported as 9 separate domain scores.
18 months
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BIS Score
BIS/BAS BIS questionnaire consists of 24 items with total scores ranging from 7-28, where higher scores indicate greater sensitivity to negative aspects of goals. BIS/BAS BIS will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Reward Responsiveness Score
BIS/BAS BAS reward responsiveness questionnaire consists of 24 items with total scores ranging from 5-20, where higher scores indicate greater tendency to be influenced by the possibility of reward when pursuing a goal. BIS/BAS BAS reward responsiveness will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Drive Score
BIS/BAS BAS drive questionnaire consists of 24 items with total scores ranging from 4-16, where higher scores indicate greater persistence in efforts towards obtaining a goal. BIS/BAS BAS drive will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score
BIS/BAS BAS fun seeking questionnaire consists of 24 items with total scores ranging from 4-16, where higher scores indicate greater tendency to be influenced by novelty and seeking out new experiences. BIS/BAS BAS fun seeking will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Social Pleasure Score
MAPS-SR social pleasure questionnaire consists of 15 items with total scores ranging from 0-12, where higher scores indicate increased pathology in this domain. MAPS-SR social pleasure will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Recreational or Work Pleasure Score
MAPS-SR recreational or work pleasure questionnaire consists of 15 items with total scores ranging from 0-12, where higher scores indicate increased pathology in this domain. MAPS-SR recreational or work pleasure will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Feelings and Motivations About Close, Caring Relationships Score
MAPS-SR feelings and motivations about close, caring relationships questionnaire consists of 15 items with total scores ranging from 0-24, where higher scores indicate increased pathology in this domain. MAPS-SR feelings and motivations about close, caring relationships will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Motivation and Effort to Engage in Activities Score
MAPS-SR motivation and effort to engage in activities questionnaire consists of 15 items with total scores ranging from 0-24, where higher scores indicate increased pathology in this domain. MAPS-SR motivation and effort to engage in activities will be assessed at baseline, 6 months, 12 months, and 18 months.
18 months
Secondary Outcomes (1)
COMPASS-10
18 months
Other Outcomes (2)
BrainHQ Cognitive Training Performance Data
12 weeks
Tolerability of BrainHQ Cognitive Training & PRIME
12 weeks
Study Arms (2)
Treatment as Usual
ACTIVE COMPARATORParticipants 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.
Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement
EXPERIMENTALThe 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.
Interventions
The Cognitive Training Module is designed to improve the speed and accuracy of auditory information processing while engaging working memory and cognitive control under conditions of close attention and reward. The goal is to increase the effectiveness by which salient stimuli engage and drive plastic changes in brain systems that in individuals with psychosis exhibit relatively poor temporal response. The Social Cognition Training Module consists of exercises designed to ameliorate core deficits in social cognition expressed in schizophrenia and Autism Spectrum Disorders. The exercises apply principles of implicit learning to restore the brain's capacity to process and utilize socially-relevant information, and include training to improve affect perception, social cue perception, theory of mind, self-referential style, and emotion labeling and working memory.
The PRIME smartphone-based app is designed to be used for 12 weeks to enhance motivation in people with early psychosis. Participants work towards self-identified goals with the support of the virtual community of age-matched peers, as well as with motivation coaches. Participants discuss their interests and aspirations with each other and with their coach, and the coach sends daily individualized motivational messages. Coaches also provide tailored interventions to enhance motivation, and post daily discussion topics to the PRIME community to encourage interaction between members. Coaches will maintain close communication and feedback on progress with each individual's clinical team.
Participants will continue to engage in treatment as usual at their early psychosis coordinated specialty care clinic. These clinics may follow the NAVIGATE model, as an example.
Eligibility Criteria
You may qualify if:
- Aged 15-40 (inclusive)
- Is enrolled in an early psychosis coordinated specialty care clinic, or is receiving services by a mental health care professional.
- Symptoms of psychosis started within the last 5 years
- Is in good general physical health (e.g., not acutely ill or experiencing a sever/chronic illness that would impede their ability to complete study activities)
- Fluent in spoken and written English
- Estimated IQ at or above 70, as estimated by the Test My Brain matrices task
- Participants will show overall clinical stability as determined by interview measures. Generally, participants who have not been hospitalized within the last 30 days, who have not had significant changes to medications, and do not have active suicidal ideation will be considered stable.
- Has access to a smart phone or other mobile device to use the PRIME App
- Has access to a computer or tablet to complete cognitive training exercises and study assessments
You may not qualify if:
- Unable to provide informed consent (i.e., cannot pass UBACC assessment)
- Participant is under legal commitment to treatment or is under medical guardianship
- Participated in significant cognitive training programs within the last 3 years
- Diagnosed with a neurological disorder that may interfere with participation in the study
- Clinically significant substance abuse that is impeding the participant's ability to participate fully during enrollment, assessment, or training (i.e., is unable to remain sober)
- Risk of suicidal behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Department of Psychiatry & Behavioral Sciences
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophia Vinogradov, MD
University of Minnesota Department of Psychiatry and Behavioral Sciences
- PRINCIPAL INVESTIGATOR
Piper Meyer-Kalos, PhD
University of Minnesota Department of Psychiatry and Behavioral Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
May 26, 2023
Study Start
May 30, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Data will be shared with the NIH Data Archive through the EPINET Data Coordinating Center