NCT02505022

Role Functioning Changes NOS

Role Functioning Changes in New Onset Symptoms

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Schizophrenia
• Psychotic Disorders
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Pharmacotherapy	Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
BEHAVIORAL	Behavioral treatment	Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2015-07-22
• Last updated: 2022-06-10

Locations

1 site across 1 country: United States