Status:
COMPLETED
Validating PROMIS Instruments in Depression
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Duke University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Brief Summary
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range...
Detailed Description
In order to validate the item banks and to examine their utility as computerized adaptive tests (CATs), the PROMIS network has designed a series of studies that will allow us to examine the attributes...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent
- Speak, read, and understand English
- Currently in the first 4 months of outpatient treatment at Western Psychiatric Institute and Clinic (WPIC) for major depressive disorder
- Participants will be required to have a minimum score of 12 on the 17-item Hamilton Rating Scale for Depression
Exclusion
- Lack of willingness or ability to provide informed consent
- Dementia or other cognitive impairment that would interfere with questionnaire completion
- Lifetime history of any psychotic disorder (e.g., schizophrenia, schizoaffective disorder) or bipolar disorder, as evidenced in the participant's medical records or reported during the Structured Clinical Interview for DSM-IV (SCID)
- Organic affective syndrome (i.e., mood disorder secondary to a general medical condition or substance-induced mood disorder)
- Current psychiatric inpatient treatment
- A history of continuous care for 1 year or more in the mental health care system within the prior 5 years (in order to eliminate patients with more chronic presentations)
- Major medical conditions that influence the central nervous system (e.g., Parkinson's disease, stroke, amyotrophic lateral sclerosis \[ALS\], multiple sclerosis \[MS\]), systemic lupus erythematosus \[SLE\], seizure disorders, etc.)
- Note: Persons with common psychiatric comorbidities (e.g., anxiety disorders) will be included. The presence of psychiatric comorbidities will be documented.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00784199
Start Date
June 1 2008
End Date
July 1 2010
Last Update
May 16 2024
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