SchizophreniaNCT02505022
Role Functioning Changes NOS
An observational study of Schizophrenia and Psychotic Disorders, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
- What is being tested?
- Pharmacotherapy and Behavioral treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Adults unable to consent
- Individuals who have not reached the age of 18
- Pregnant women
- Prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role Functioning Changes in New Onset Symptoms
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.
Read the 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
- Being tested
- Pharmacotherapy, Behavioral treatment
- Keywords
- Cognition, Early mental illness, Role functioning
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacotherapyDrug
Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
Behavioral treatmentBehavioural
Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pharmacotherapy; Behavioral: Behavioral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition
Measured: 1 year
Secondary outcomes (12)
PONS
Profile of non-verbal sensitivity
Measured: 1 year
TASIT
The Awareness of Social Inference Test
Measured: 1 year
BLERT
Bell-Lysaker Emotion Recognition Task
Measured: 1 year
SFS
Social Functioning Scale
Measured: 1 year
UPSA
UCSD Performance-Based Skills Assessment
Measured: 1 year
EPT
Emotional Perspective-Taking Task
Measured: 1 year
FAP
Facial Affect Perception Task
Measured: 1 year
Informant SLOF
Informant Specific Levels of Functioning Scale; administered to an informant of a participant
Measured: 1 year
SLOF
Specific Levels of Functioning Scale
Measured: 1 year
RFS
Role Functioning Scale
Measured: 1 year
ERS
Emotional Reactivity Scale
Measured: 1 year
ASSIST
Alcohol, Smoking and Substance Involvement Screening Test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Will Cronenwett, Northwestern University
- Investigators
- Will J Cronenwett, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505022
- Sponsor's protocol ID
- STU00201133
- Status last verified
- Jun 2022
- First submitted
- 20 Jul 2015
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Functioning Changes in New Onset Symptoms
- ClinicalTrials.gov ID
- NCT02505022
- Acronym / sponsor ID
- STU00201133
- Conditions
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
- Keywords
- Cognition, Early mental illness, Role functioning
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment seeking patients | – | Drug: Pharmacotherapy, Behavioral: Behavioral treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Adults unable to consent
- Individuals who have not reached the age of 18
- Pregnant women
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacotherapyParticipants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered. | Drug | Treatment seeking patients |
| Behavioral treatmentParticipants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered. | Behavioural | Treatment seeking patients |
Primary outcome
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition
Time frame: 1 year
12 secondary outcomes
PONS
Time frame: 1 year
TASIT
Time frame: 1 year
BLERT
Time frame: 1 year
SFS
Time frame: 1 year
UPSA
Time frame: 1 year
EPT
Time frame: 1 year
FAP
Time frame: 1 year
Informant SLOF
Time frame: 1 year
SLOF
Time frame: 1 year
RFS
Time frame: 1 year
ERS
Time frame: 1 year
ASSIST
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will J Cronenwett, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychotic Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlates between Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.