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| Sponsors and Collaborators: |
National Institutes of Health (NIH) Duke University Evanston Northwestern Healthcare The University of North Carolina, Chapel Hill University of Pittsburgh Stanford University Stony Brook University University of Washington |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00784199 |
Purpose
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 of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
| Condition |
|---|
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Major Depressive Disorder |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Validating PROMIS Instruments in Depression |
| Estimated Enrollment: | 115 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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 of the measures in "real-world" clinical environments. This protocol is aimed at comparing the psychometric properties of the PROMIS item banks with non-PROMIS "gold standard" instruments currently used in our respective fields (pain and mental health). In this context, note that the proposed study is not intended to evaluate treatment effectiveness, and no control group has been included. The main consideration has been to design a study involving ecologically valid treatments with established efficacy that can be administered and evaluated over the short term (i.e., 3 months). Regardless of their impact in the aggregate, such treatments will generate considerable variability in individual outcomes, and this heterogeneity is optimal for examining relevant psychometric issues. The psychometric issue of greatest concern is the validity of the PROMIS item banks as evidenced in convergent and discriminant validity and responsiveness to change. We also will make initial estimates of clinically significant change as reflected in our PROMIS measures. By combining efforts of the two sites that led in the development of the item banks for emotional distress (University of Pittsburgh) and pain (University of Washington), the study will maximize total sample size and provide a fertile ground for analyses of psychometric functioning of the PROMIS banks.
In addition to psychometric questions, we will also address clinically meaningful questions related to pain, depression, and the relationship between the two. The complex relationship between pain and depression has been observed for years. Both syndromes are mutually exacerbating—pain worsens depression and depression worsens the experience of pain. The domain-related issues of greatest interest focus on the interaction between depression and pain and its impact on treatment outcome (including changes in symptoms of both depression and pain, in acute clinical status, and in social functioning).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adults who have started treatment for an episode of major depressive disorder in the last 4 months at Western Psychiatric Institute and Clinic (WPIC) in Pittsburgh, PA. WPIC houses the Department of Psychiatry at the University of Pittsburgh Medical Center (UPMC) and serves as the flagship for the UPMC Behavioral Health Network, the psychiatric specialty division of the UPMC Health System. Each year, WPIC provides more than 350,000 patient contacts in its ambulatory care sites.
Inclusion Criteria:
Exclusion Criteria:
Note: Persons with common psychiatric comorbidities (e.g., anxiety disorders) will be included. The presence of psychiatric comorbidities will be documented.
Contacts and Locations| Contact: Angela Stover, MA | 412-246-5551 | stoveram@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Angela Stover, MA 412-246-5551 stoveram@upmc.edu | |
| Principal Investigator: Paul A Pilkonis, PhD | |
| Sub-Investigator: Jordan Karp, MD | |
| Sub-Investigator: Lan Yu, PhD | |
| Principal Investigator: | Paul A Pilkonis, PhD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Paul Pilkonis ) |
| Study ID Numbers: | 07-04a |
| Study First Received: | October 30, 2008 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00784199 |
| Health Authority: | United States: Federal Government |
|
MDD Depression |
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Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
