Validating PROMIS Instruments in Depression

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).

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.