Role Functioning Changes NOS

Sponsor

Northwestern University (Other)

Overall Status

Terminated

CT.gov ID

NCT02505022

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychotic Disorders Bipolar Disorder	Drug: Pharmacotherapy Behavioral: Behavioral treatment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Role Functioning Changes in New Onset Symptoms

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition [1 year]

Secondary Outcome Measures

PONS [1 year]
Profile of non-verbal sensitivity
TASIT [1 year]
The Awareness of Social Inference Test
BLERT [1 year]
Bell-Lysaker Emotion Recognition Task
SFS [1 year]
Social Functioning Scale
UPSA [1 year]
UCSD Performance-Based Skills Assessment
EPT [1 year]
Emotional Perspective-Taking Task
FAP [1 year]
Facial Affect Perception Task
Informant SLOF [1 year]
Informant Specific Levels of Functioning Scale; administered to an informant of a participant
SLOF [1 year]
Specific Levels of Functioning Scale
RFS [1 year]
Role Functioning Scale
ERS [1 year]
Emotional Reactivity Scale
ASSIST [1 year]
Alcohol, Smoking and Substance Involvement Screening Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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