EPI-MINN: Targeting Cognition and Motivation

NCT05112432 | Active Not Recruiting FDA Device

• 3 other identifiers: PSYCH-2021-30030Pro000494911R01MH120589
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well-defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study. 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. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not. This study will be conducted jointly with a sister protocol under a separate NCT listing. This iteration will be conducted locally within the EPI-MINN Network, while the other project will be conducted on a national scale.

Conditions

Psychosis

Keywords

Cognitive Training; Motivation Enhancement; First Episode Psychosis; Schizophrenia Spectrum Disorders

Outcome Measures

Primary Outcomes (12)

• Change Penn Computerized Neuropsychological Testing System (Penn CNP) Scores

  Penn CNP is reported as the total score on 4 cognitive domains. The DSST ranges from 0-300+, the PWMT ranges from 0-40, the PMAT ranges from 0-24, and the ER-40 ranges from 0-40. Penn CNP will be assessed at baseline, during pre-training, at 6 months, 12 months, and 18 months. Higher accuracy scores indicate higher cognitive function and lower reaction time scores indicate faster reaction time. Reaction time is reported in milliseconds. Performance score is calculated based on accuracy and reaction speed.

  18 months

• 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 COMPARATOR

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.

Other: Early Psychosis Coordinated Specialty Care

Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME)

EXPERIMENTAL

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.

Device: Cognitive and Social Cognitive Training; Behavioral: Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App; Other: Early Psychosis Coordinated Specialty Care

Interventions

Cognitive and Social Cognitive Training DEVICE

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. Exercises continuously adjust difficulty level to user performance to maintain an approximately 80% current performance rate. 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.

Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME)

Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App BEHAVIORAL

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.

Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME)

Early Psychosis Coordinated Specialty Care OTHER

Participants will continue to receive treatment as usual at their early psychosis coordinated specialty care clinics. These clinics may follow the NAVIGATE model, as an example.

Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement App (PRIME); Treatment as Usual

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
• Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
• Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
• Has access to a smartphone or other mobile device to use the PRIME app

You may not qualify if:

• 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
• Participated in significant cognitive training programs within the last three years
• Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
• Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training)
• Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
• Active suicidal ideation at screening or baseline, or
• Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Human Development Center

Duluth, Minnesota, 55805, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

PRIME protocol; Amyloid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota Department of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

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: October 27, 2021
• First Posted: November 8, 2021
• Study Start: August 12, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (3)