An observational study in Schizophrenia, Psychotic Disorders and Bipolar Disorder, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Northwestern University · Observational
During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. This will happen in the context of providing treatment-as-usual to individuals who arrive seeking help with the early phases of mental illness.
The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan.
While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 28 is below the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
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Young adults with emerging psychopathology. Therefore, all subjects we recruit will be in the age range spanning adolescence and young adulthood, who come to a clinic seeking psychiatric care.
Exclusion Criteria:
Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning.
Drug: Pharmacotherapy · Behavioral: Behavioral treatment
Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition
Time frame: 1 year
PONS
Profile of non-verbal sensitivity
Time frame: 1 year
TASIT
The Awareness of Social Inference Test
Time frame: 1 year
BLERT
Bell-Lysaker Emotion Recognition Task
Time frame: 1 year
SFS
Social Functioning Scale
Time frame: 1 year
UPSA
UCSD Performance-Based Skills Assessment
Time frame: 1 year
EPT
Emotional Perspective-Taking Task
Time frame: 1 year
FAP
Facial Affect Perception Task
Time frame: 1 year
Informant SLOF
Informant Specific Levels of Functioning Scale; administered to an informant of a participant
Time frame: 1 year
SLOF
Specific Levels of Functioning Scale
Time frame: 1 year
RFS
Role Functioning Scale
Time frame: 1 year
ERS
Emotional Reactivity Scale
Time frame: 1 year
ASSIST
Alcohol, Smoking and Substance Involvement Screening Test
Time frame: 1 year
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Northwestern University