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Role Functioning Changes NOS

Role Functioning Changes in New Onset Symptoms

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02505022
Enrollment
28
Registered
2015-07-22
Start date
2016-01-31
Completion date
2021-01-31
Last updated
2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Psychotic Disorders, Bipolar Disorder

Keywords

Cognition, Early mental illness, Role functioning

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.

Interventions

Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.

BEHAVIORALBehavioral treatment

Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition1 year

Secondary

MeasureTime frameDescription
TASIT1 yearThe Awareness of Social Inference Test
BLERT1 yearBell-Lysaker Emotion Recognition Task
SFS1 yearSocial Functioning Scale
UPSA1 yearUCSD Performance-Based Skills Assessment
EPT1 yearEmotional Perspective-Taking Task
PONS1 yearProfile of non-verbal sensitivity
Informant SLOF1 yearInformant Specific Levels of Functioning Scale; administered to an informant of a participant
SLOF1 yearSpecific Levels of Functioning Scale
RFS1 yearRole Functioning Scale
ERS1 yearEmotional Reactivity Scale
ASSIST1 yearAlcohol, Smoking and Substance Involvement Screening Test
FAP1 yearFacial Affect Perception Task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026