Major Depressive DisorderNCT00784199
Validating PROMIS Instruments in Depression
An observational study of Major Depressive Disorder, run by University of Pittsburgh.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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 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).
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessments at baseline, 1 month, and 3-month follow-up
Secondary outcomes (1)
Judgments of clinically significant change (via diagnostic interviews) and comparison of these changes with the changes reflected in the PROMIS measures
Measured: Assessments at baseline, 1 month, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Duke University, Endeavor Health, University of North Carolina, Chapel Hill, Stanford University, Stony Brook University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Paul A Pilkonis, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784199
- Sponsor's protocol ID
- PRO07070241
- Other IDs
- 5U01AR052155-02, 2U01AR052155-06
- Status last verified
- May 2013
- First submitted
- 30 Oct 2008
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating PROMIS Instruments in Depression
- ClinicalTrials.gov ID
- NCT00784199
- Acronym / sponsor ID
- PRO07070241
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Duke University, Endeavor Health, University of North Carolina, Chapel Hill, Stanford University, Stony Brook University, University of Washington
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Nov 2008 (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.
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.
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 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Assessments at baseline, 1 month, and 3-month follow-up
1 secondary outcome
Judgments of clinically significant change (via diagnostic interviews) and comparison of these changes with the changes reflected in the PROMIS measures
Time frame: Assessments at baseline, 1 month, and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Paul A Pilkonis, PhD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by University of Pittsburgh.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: Assessments at baseline, 1 month, and 3-month follow-up). 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 16 May 2024.