Role Functioning Changes NOS

NCT ID: NCT02505022

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-01-31

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.

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pharmacotherapy

Intervention Type: DRUG

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

Behavioral treatment

Intervention Type: BEHAVIORAL

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

Interventions

Pharmacotherapy

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

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Will Cronenwett

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Will J Cronenwett, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00201133

Identifier Type: -

Identifier Source: org_study_id