Validating PROMIS Instruments in Depression

Major Depressive Disorder Clinical Trial

Official title:

Validating PROMIS Instruments in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784199
• Other study ID #: PRO07070241
• Secondary ID: 5U01AR052155-022
• Status: Completed
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: May 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
University of Pittsburgh	Duke University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NorthShore University HealthSystem, Stanford University, Stony Brook University, University of North Carolina, Chapel Hill, University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS computerized adaptive tests (CATs) for pain, fatigue, social functioning, depression, anxiety, anger, sleep, wake, and physical functioning, and non-PROMIS measures (conventional instruments) also administered by computer		Assessments at baseline, 1 month, and 3-month follow-up
Secondary	Judgments of clinically significant change (via diagnostic interviews) and comparison of these changes with the changes reflected in the PROMIS measures		Assessments at baseline, 1 month, and 3-month follow-up