Role Functioning Changes NOS

Schizophrenia Clinical Trial

Official title:

Role Functioning Changes in New Onset Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02505022
• Other study ID #: STU00201133
• Status: Terminated
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: June 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition		1 year
Secondary	PONS	Profile of non-verbal sensitivity	1 year
Secondary	TASIT	The Awareness of Social Inference Test	1 year
Secondary	BLERT	Bell-Lysaker Emotion Recognition Task	1 year
Secondary	SFS	Social Functioning Scale	1 year
Secondary	UPSA	UCSD Performance-Based Skills Assessment	1 year
Secondary	EPT	Emotional Perspective-Taking Task	1 year
Secondary	FAP	Facial Affect Perception Task	1 year
Secondary	Informant SLOF	Informant Specific Levels of Functioning Scale; administered to an informant of a participant	1 year
Secondary	SLOF	Specific Levels of Functioning Scale	1 year
Secondary	RFS	Role Functioning Scale	1 year
Secondary	ERS	Emotional Reactivity Scale	1 year
Secondary	ASSIST	Alcohol, Smoking and Substance Involvement Screening Test	1 year