EPI-MINN: Targeting Cognition and Motivation

NCT ID: NCT05112432

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2026-07-31

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.

Detailed Description

Cognitive dysfunction is a core pathophysiological feature of psychosis and one of the strongest predictors of functional outcomes. Several studies indicate that current early intervention programs may not significantly alter long-term clinical outcome, suggesting that critical treatment target(s), beyond symptoms and functional status, are not being addressed. Evidence strongly indicates that, along with cognitive dysfunction, impaired motivation is also a critical target and unmet therapeutic need.

The application of effective treatment to improve cognition in early phases of psychosis has a very high likelihood of significantly improving long-term community functioning. The investigators have demonstrated both behavioral gains and improved neural system functioning after neuroscience-informed cognitive training in schizophrenia, in both chronic and early phases of the illness. In young recent-onset individuals (average age of 21 years), the investigators' multi-site double-blind randomized controlled trial showed that 40 hours/ 10 weeks of cognitive training delivered at home over a laptop resulted in significant gains in global cognition, verbal memory, and problem solving compared to a computer games control condition. Cognitive gains were significantly correlated with enhanced thalamic volume and thalamo-cortical connectivity, as well as increased white matter integrity. A meta-analysis of 11 RCTs in early schizophrenia has also indicated the benefit of cognitive remediation approaches.

Impaired motivation is also a core feature and very strong predictor of functional outcome in early stages of psychosis. Some studies have shown positive effects in improving motivation immediately after the intervention, but treatments that induce enduring improvements in motivated behavior are scarce. Disturbances in motivated behavior reflect a range of factors, including diminished anticipatory pleasure, difficulty learning from rewarding outcomes, reduction in effort expended to obtain rewarding outcomes, and impairment and disconnection between components of social motivation. This makes it difficult to determine optimal therapeutic approaches. However, some headway is starting to appear in the literature. For instance, social cognition impairments appear to play a specific contributing role to dysfunctions in motivated behavior, and are amenable to intervention. We have found that ratings of motivated behavior improve after social cognition training, and are significantly greater in subjects who performed cognitive training combined with social cognition training, than in those who completed only cognitive training. The investigators have also demonstrated a significant relationship between 6-month social functioning and training-induced improvements in the neural correlates of a self-other reality monitoring task. These data, along with the literature on reward anticipation and on social engagement in psychosis, led this group to work with young clients in a user-centered design process, to develop a mobile app called Personalized Real-time Intervention for Motivational Enhancement (PRIME). The app has been extremely well received by users and published behavioral findings are highly promising. Thus, the investigators will combine a focused course of cognitive plus social cognitive training (delivered remotely) with PRIME, to address the cognitive dysfunction and impaired motivation.

Functional recovery lags behind symptom recovery in early intervention programs, is sometimes difficult for individuals to attain, and is closely aligned with cognitive and motivational deficits. How could outcomes for individuals with early psychosis to improved? The results from the EPI-MINN: Measurement-Based Care study will provide data-driven knowledge on factors that contribute to 2-year treatment response trajectories in early psychosis. This knowledge will be combined with insights from the investigators' current study to deepen understanding of methods to optimize coordinated specialty care to improve clinical trajectories, using a well-defined scalable mobile program that addresses as-of-yet unmet therapeutic needs.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Early Psychosis Coordinated Specialty Care

Intervention Type: 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)

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 Type: EXPERIMENTAL

Cognitive and Social Cognitive Training

Intervention Type: 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.

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

Intervention Type: 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.

Early Psychosis Coordinated Specialty Care

Intervention Type: 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.

Interventions

Cognitive and Social Cognitive Training

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.

Intervention Type: DEVICE

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

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.

Intervention Type: BEHAVIORAL

Early Psychosis Coordinated Specialty Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophia Vinogradov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Department of Psychiatry and Behavioral Sciences

Locations

Human Development Center

Duluth, Minnesota, United States

Hennepin Healthcare

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

Pro00049491

Identifier Type: OTHER

Identifier Source: secondary_id

1R01MH120589

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSYCH-2021-30030

Identifier Type: -

Identifier Source: org_study_id