Role Functioning Changes NOS

NCT02505022 | Terminated

• 1 other identifier: STU00201133
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Keywords

Cognition; Early mental illness; Role functioning

Outcome Measures

Primary Outcomes (1)

• Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition

  1 year

Secondary Outcomes (12)

• PONS

  1 year

• TASIT

  1 year

• BLERT

  1 year

• SFS

  1 year

• UPSA

  1 year

Study Arms (1)

Treatment seeking patients

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

Interventions

Pharmacotherapy DRUG

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

Treatment seeking patients

Behavioral treatment BEHAVIORAL

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

Treatment seeking patients

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Adults unable to consent
• Individuals who have not reached the age of 18
• Pregnant women
• Prisoners.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mental Disorders

Interventions

Drug Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Will J Cronenwett, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

US (1)