Clinical trial NCT05877716: EPI-MINN: Targeting Cognition and Motivation - National
Official title: EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A National Comparison Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Psychosis Nos/Other
Schizophrenia
Schizo Affective Disorder
Schizoaffective Disorder
Prodromal Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophreniform Disorders
Major Depression With Psychotic Features
Unspecified Psychosis
Bipolar Disorder
Keywords: Cognitive Training
Motivation Enhancement
First Episode Psychosis
Schizophrenia Spectrum Disorders
Remote
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 this study will provide data-driven knowledge on factors that contribute to 2-year treatment response trajectories in early psychosis. The knowledge gained from this clinical trial will 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Test My Brain Scores
timeFrame: 18 months
measure: Change in Dysfunctional Attitudes Scale - Defeatist Beliefs Subscale (DAS-DB) Score
timeFrame: 18 months
measure: Quality of Life Scale - Abbreviated
timeFrame: 18 months
measure: Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BIS Score
timeFrame: 18 months
measure: Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Reward Responsiveness Score
timeFrame: 18 months
measure: Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Drive Score
timeFrame: 18 months
measure: Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score
timeFrame: 18 months
measure: Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Social Pleasure Score
timeFrame: 18 months
measure: Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Recreational or Work Pleasure Score
timeFrame: 18 months
measure: Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Feelings and Motivations About Close, Caring Relationships Score
timeFrame: 18 months
measure: Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Motivation and Effort to Engage in Activities Score
timeFrame: 18 months
Secondary outcomes:
measure: COMPASS-10
timeFrame: 18 months
Other outcomes:
measure: BrainHQ Cognitive Training Performance Data
timeFrame: 12 weeks
measure: Tolerability of BrainHQ Cognitive Training & PRIME
timeFrame: 12 weeks
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Department of Psychiatry & Behavioral Sciences
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Psychiatry and Behavioral Sciences
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota Department of Psychiatry and Behavioral Sciences
name: Piper Meyer-Kalos, PhD
role: PRINCIPAL_INVESTIGATOR
References: