Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT02505022 |
Other study ID # |
STU00201133 |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 2016 |
Est. completion date |
January 2021 |
Study information
Verified date |
June 2022 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.