Schizophrenia Clinical Trial
Official title:
EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A National Comparison Study
NCT number | NCT05877716 |
Other study ID # | STUDY00018733 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2023 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Department of Psychiatry & Behavioral Sciences | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | BrainHQ Cognitive Training Performance Data | The number of hours of training completed will be reported ranging from 0-20. | 12 weeks | |
Other | Tolerability of BrainHQ Cognitive Training & PRIME | 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. | 12 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 18 months |
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