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EPI-MINN: Targeting Cognition and Motivation - National

Primary Purpose

Psychosis, Psychosis Nos/Other, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive and Social Cognitive Training
Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App
Early Psychosis Coordinated Specialty Care
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Cognitive Training, Motivation Enhancement, First Episode Psychosis, Schizophrenia Spectrum Disorders, Remote

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-40 (inclusive) Is enrolled in an early psychosis coordinated specialty care clinic In in good general phsycial 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 hospilatlized within the last 30 days 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

Sites / Locations

  • University of Minnesota Department of Psychiatry & Behavioral SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual

Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

COMPASS-10
The Compass-10 scale consists of 10 items rated on a scale from 0 to 6, with higher scores indicating more severe symptoms of depression and anxiety. Outcome will be reported as 10 separate domain scores.

Full Information

First Posted
May 17, 2023
Last Updated
June 22, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05877716
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 receiving care at coordinated specialty care (CSC) early psychosis clinics across the United States will be recruited to participate in this study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cognitive Training plus Personalized Real-Time Intervention for Motivational Enhancement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cognitive and Social Cognitive Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App
Intervention Description
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
Other
Intervention Name(s)
Early Psychosis Coordinated Specialty Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Test My Brain Scores
Description
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.
Time Frame
18 months
Title
Change in Dysfunctional Attitudes Scale - Defeatist Beliefs Subscale (DAS-DB) Score
Description
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.
Time Frame
18 months
Title
Quality of Life Scale - Abbreviated
Description
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.
Time Frame
18 months
Title
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BIS Score
Description
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.
Time Frame
18 months
Title
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Reward Responsiveness Score
Description
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.
Time Frame
18 months
Title
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Drive Score
Description
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.
Time Frame
18 months
Title
Change in Behavioral Inhibition and Activation Scale (BIS/BAS) - BAS Fun Seeking Score
Description
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.
Time Frame
18 months
Title
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Social Pleasure Score
Description
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.
Time Frame
18 months
Title
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Recreational or Work Pleasure Score
Description
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.
Time Frame
18 months
Title
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Feelings and Motivations About Close, Caring Relationships Score
Description
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.
Time Frame
18 months
Title
Change in Motivation and Pleasure Scale - Self Report (MAPS-SR) - Motivation and Effort to Engage in Activities Score
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
COMPASS-10
Description
The Compass-10 scale consists of 10 items rated on a scale from 0 to 6, with higher scores indicating more severe symptoms of depression and anxiety. Outcome will be reported as 10 separate domain scores.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
BrainHQ Cognitive Training Performance Data
Description
The number of hours of training completed will be reported ranging from 0-20.
Time Frame
12 weeks
Title
Tolerability of BrainHQ Cognitive Training & PRIME
Description
This measure contains both qualitative and quantitative information. Participants will compete questionnaires regarding the tolerability for PRIME and the tolerability of BrainHQ cognitive training. A global score will be calculated and participants are categorized as low tolerability, medium tolerability, or high tolerability. Outcome will be reported as the number of participants in each tolerability category - low, medium, and high.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-40 (inclusive) Is enrolled in an early psychosis coordinated specialty care clinic In in good general phsycial 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 hospilatlized within the last 30 days 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nate Olinger
Phone
612-403-4587
Email
epinetrct@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Currie
Phone
612-626-7261
Email
curri105@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Vinogradov, MD
Organizational Affiliation
University of Minnesota Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piper Meyer-Kalos, PhD
Organizational Affiliation
University of Minnesota Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Department of Psychiatry & Behavioral Sciences
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Currie
Phone
612-626-7261
Email
curri105@umn.edu
First Name & Middle Initial & Last Name & Degree
Melissa Fisher, Ph.D.
First Name & Middle Initial & Last Name & Degree
Lionel Wininger, PhD
First Name & Middle Initial & Last Name & Degree
Melissa Dalhoe, MSW, LICSW
First Name & Middle Initial & Last Name & Degree
Jewels Lindholm, LICSW
First Name & Middle Initial & Last Name & Degree
Aimee Murray, PsyD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with the NIH Data Archive through the EPINET Data Coordinating Center

Learn more about this trial

EPI-MINN: Targeting Cognition and Motivation - National

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