Role Functioning Changes NOS

Terminated

• Conditions: Schizophrenia; Psychotic Disorders; Bipolar Disorder
• Interventions: Drug: Pharmacotherapy; Behavioral: Behavioral treatment

• Registration Number: NCT02505022
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Study Start: 2016-01
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment seeking patients	Pharmacotherapy	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.
Treatment seeking patients	Behavioral treatment	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.

Primary Outcome Measures

Name	Time	Method
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition	1 year

Secondary Outcome Measures

Name	Time	Method
TASIT	1 year	The Awareness of Social Inference Test
PONS	1 year	Profile of non-verbal sensitivity
BLERT	1 year	Bell-Lysaker Emotion Recognition Task
SFS	1 year	Social Functioning Scale
RFS	1 year	Role Functioning Scale
ERS	1 year	Emotional Reactivity Scale
ASSIST	1 year	Alcohol, Smoking and Substance Involvement Screening Test
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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States