Clinical trial NCT02505022: Role Functioning Changes NOS
Official title: Role Functioning Changes in New Onset Symptoms
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Psychotic Disorders
Bipolar Disorder
Keywords: Cognition
Early mental illness
Role functioning
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 26 years
2. Individuals seeking treatment for psychiatric symptoms in a clinical care setting
3. Able to provide informed consent (age 18-26)
4. Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
5. Fluent in English

Exclusion Criteria:

1. Adults unable to consent
2. Individuals who have not reached the age of 18
3. Pregnant women
4. Prisoners.

Primary outcomes:
measure: Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition
timeFrame: 1 year
Secondary outcomes:
measure: PONS
timeFrame: 1 year
measure: TASIT
timeFrame: 1 year
measure: BLERT
timeFrame: 1 year
measure: SFS
timeFrame: 1 year
measure: UPSA
timeFrame: 1 year
measure: EPT
timeFrame: 1 year
measure: FAP
timeFrame: 1 year
measure: Informant SLOF
timeFrame: 1 year
measure: SLOF
timeFrame: 1 year
measure: RFS
timeFrame: 1 year
measure: ERS
timeFrame: 1 year
measure: ASSIST
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Will J Cronenwett, MD
role: PRINCIPAL_INVESTIGATOR
References: