EICHORCondition: Psychosis · Sponsor: University of Minnesota
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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.
This description comes directly from the study's public registry record.
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Human Development Center | Duluth, Minnesota, United States | — |
| Hennepin Healthcare | Minneapolis, Minnesota, United States | — |
| University of Minnesota | Minneapolis, Minnesota, United States | — |
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Source record: clinicaltrials.gov/study/NCT05112432