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Posttraumatic Stress Disorder (PTSD)STEPS UPNCT01492348

Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial

A study testing STEPS UP and OUC in people with Posttraumatic Stress Disorder (PTSD) and Depression, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
STEPS UP and OUC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
666 participants
Where
6 sitesUnited States
Study dates
Jan 2012to Feb 2016
Phase
Interventional
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active duty status at the time of enrollment
  • Positive PTSD screen (2 or more yes responses on PC-PTSD), per routine primary care screening.
  • DSM-IV-TR criteria for A) PTSD using the PCL-C (i.e.., a "moderate" or greater severity level on 1 re-experiencing, 3 avoidance, and 2 hyperarousal symptoms) and/or B) Depression, using the PHQ-9 (i.e., endorsement of at least 5 of the 9 symptoms experienced "more than half the days" and at least one of those symptoms must include either "little interest or pleasure in doing things" or "feeling down, depressed or hopeless")
  • Report of routine computer, Internet, and e-mail access
  • Capacity to consent to participation and provide research informed consent using local IRB-approved form

Who cannot join

  • Treatment refractory PTSD or depression after participation in RESPECT-mil or specialty mental health treatment.
  • Acute psychosis, psychotic episode, or psychotic disorder diagnosis by history within the past 2 years
  • Bipolar I disorder by history or medical record review within last 2 years.
  • Active substance dependence disorder in the past year by history within the past 12 months.
  • Active suicidal ideation within the past 2 months by history.
  • Patients on psychoactive medication, unless that medication dosing and administration has been stable and regular for at least 1 month.
Show all 9Show fewer
  • Acute or unstable physical illness.
  • Anticipated deployment, demobilization, or separation during the next six months.
  • Personnel who work in participating clinics.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • William Beaumont Army Medical Center

    Fort Bliss, Texas, 79920-5001

  • Womack Army Medical Center

    Fort Bragg, North Carolina, 28310

  • Blanchfield Army Community Hospital

    Fort Campbell, Kentucky, 42333

  • Evans Army Community Hospital

    Fort Carson, Colorado, 80913

  • Winn Army Community Hospital

    Fort Stewart, Georgia, 31409-5102

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

Other trials in United States

About this study

The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More specifically, the investigators will test the effectiveness of a telephone care management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC).

Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and depression symptom severity compared to participants assigned to OUC over 12-months of follow-up.

Read more

Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater improvements in somatic symptom severity, alcohol use, mental health functioning, and work functioning compared to participants assigned to OUC over 12-months of follow-up.

Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in terms of dollars per quality adjusted life years saved.

Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians, care managers, and family members will report that STEPS UP is acceptable, effective, satisfying, and appropriate PTSD and depression care.

Read the detailed description

Despite the significant prevalence of posttraumatic stress disorder (PTSD) and depression among veterans returning from Operations in Iraq and Afghanistan, less than half of service members who are referred for a specialty mental health assessment actually receive specialty mental health treatment. Systematic knowledge regarding access to care and quality of care delivered in civilian, VA, and military facilities for those who encounter barriers or difficulty is scant, and recent policy reviews have strongly questioned availability and quality of care. These problems of access and quality are major, overarching problems in war-related PTSD research. There are scientifically tested strategies from non-military settings and for other mental disorders to improve access to and quality of care; unfortunately, these strategies are unstudied in the military health system and for PTSD and depression. These strategies include care manager coordination (connecting patient, provider, and specialist), collaborative care (negotiated patient-provider problem definition, monitoring of status and treatment response, self-management support, telehealth sustained follow-up), and stepped care (logical, patient-centered and guideline-concordant treatment sequencing). This study aims to fill these gaps and evaluate these systems-level strategies in a military setting for PTSD and depression.

The purpose of the STEPS UP (STepped Enhancement of PTSD Services Using Primary Care) trial is to compare centralized telephonic care management with preference-based stepped PTSD and depression care to optimized usual care. We hypothesize that the STEPS UP intervention will lead to improvements in (1) PTSD and depression symptom severity (primary hypothesis); (2) somatic symptom severity, alcohol use, mental health functioning, work functioning; (3) costs and cost-effectiveness. We further hypothesize that qualitative data obtained from interviews will show that (4) patients, their family members, and participating clinicians find the STEPS-UP intervention to be an acceptable, effective, and satisfying approach to deliver and receive PTSD and depression care.

STEPS-UP is a six-site, two-parallel arm (N = 666) randomized controlled effectiveness trial with 3-month, 6-month, and 12-month follow-up comparing centralized telephonic stepped-care management to optimized usual PTSD and depression care. In addition to the existing PTSD and depression treatment options, STEPS UP includes web-based cognitive behavioral self-management, telephone cognitive-behavioral therapy, continuous RN nurse care management, and computer-automated care management support. Both arms can refer patients for mental health specialty care as needed, preferred and available. The study uses sites currently running RESPECT-Mil, the existing military primary care-mental health services practice network, to access site health care leaders and potential study participants at the 6 study sites.

If effective, we expect that STEPS UP will increase the percentage of military personnel with unmet PTSD- and depression-related health care needs who get timely, effective, and efficient PTSD and depression care. Our real-world primary care effectiveness emphasis will prevent the Institute of Medicine's so called "15 year science to service gap." If successful, STEPS UP could roll out immediately, reinforcing and facilitating pathways to PTSD and depression recovery.

Being tested
STEPS UP, OUC
Keywords
collaborative care, PTSD, military, Depression, primary care, care management, stepped care, telehealth, OIF, OEF, preference-based treatment, cost effectiveness, web-based treatment, telephonic CBT, evidence-based treatment
Medical subject headings
Stress Disorders, Post-Traumatic, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STEPS UPBehavioural

    The STEPS UP intervention enhances RESPECT-Mil in several ways:

    1. Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement.
    2. Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, \& primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist.
    3. Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours.
    4. Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components.

  • OUCBehavioural

    Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the "three-component model" where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist.

Study groups in NCT01492348
Study groupRoleWhat they receive
STEPS UP InterventionExperimentalSTEPS UP is a centrally assisted stepped collaborative telecare management program within primary care. The STEPS UP intervention added to Optimized Usual Care (PCMH-BH; formerly RESPECT-Mil) in 4 ways: (1) care management enhancements; (2) stepped psychosocial treatment options (web, phone, in person); (3) electronic symptom registry for measurement-based treatment planning (symptoms are measured at regular intervals and care is intensified for patients with recurrent or persistent PTSD and/or depressive) and for telecare manager caseload and site performance monitoring; and (4) routine assisted review of patient, telecare manager, and site performance by a central psychiatrist and psychologist.
Receives: Behavioral: STEPS UP
Optimized Usual Care (OUC)Active comparatorService members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system.
Receives: Behavioral: OUC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Posttraumatic Diagnostic Scale (PDS)

    The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.

    Measured: baseline - 3 months

  2. Posttraumatic Diagnostic Scale (PDS)

    The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.

    Measured: baseline - 6 months

  3. Posttraumatic Diagnostic Scale (PDS)

    The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.

    Measured: baseline - 12 months

  4. Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)

    The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).

    Measured: baseline - 3 months

  5. Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)

    The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).

    Measured: baseline - 6 months

  6. Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)

    The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).

    Measured: baseline - 12 months

Secondary outcomes (15)

  1. Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

    Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, \& Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).

    Measured: baseline - 3 months

  2. Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

    Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, \& Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).

    Measured: baseline - 6 months

  3. Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

    Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, \& Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).

    Measured: baseline - 12 months

  4. Alcohol Use Disorders Identification Test (AUDIT)

    The AUDIT (Babor, Higgins-Biddle, Saunders, \& Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, \& Babor, 1997; Saunders, Aasland, Amundsen, \& Grant, 1993; Saunders, Aasland, Babor, de, \& Grant, 1993)

    Measured: eligibility - 3 months

  5. Alcohol Use Disorders Identification Test (AUDIT)

    The AUDIT (Babor, Higgins-Biddle, Saunders, \& Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, \& Babor, 1997; Saunders, Aasland, Amundsen, \& Grant, 1993; Saunders, Aasland, Babor, de, \& Grant, 1993)

    Measured: eligibility - 6 months

  6. Alcohol Use Disorders Identification Test (AUDIT)

    The AUDIT (Babor, Higgins-Biddle, Saunders, \& Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, \& Babor, 1997; Saunders, Aasland, Amundsen, \& Grant, 1993; Saunders, Aasland, Babor, de, \& Grant, 1993)

    Measured: eligibility - 12 months

  7. Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)

    Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.

    Measured: baseline - 3 months

  8. Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)

    Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.

    Measured: baseline - 6 months

  9. Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)

    Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.

    Measured: baseline - 12 months

  10. WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)

    The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.

    Measured: baseline - 3 months

  11. WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)

    The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.

    Measured: baseline - 6 months

  12. WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)

    The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.

    Measured: baseline - 12 months

  13. Numeric Rating Scale for Pain

    This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994) and the University of Washington's IMPACT studies. The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.

    Measured: baseline - 3 months

  14. Numeric Rating Scale for Pain

    This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994) and the University of Washington's IMPACT studies. The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.

    Measured: baseline - 6 months

  15. Numeric Rating Scale for Pain

    This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994) and the University of Washington's IMPACT studies. The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.

    Measured: baseline - 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2014
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492348
Sponsor's protocol ID
W81XWH-09-2-0077
Acronym
STEPS UP
Status last verified
Mar 2017
First submitted
31 Mar 2010
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Engel CC. Improving primary care for military personnel and veterans with posttraumatic stress disorder--the road ahead. Gen Hosp Psychiatry. 2005 May-Jun;27(3):158-60. doi: 10.1016/j.genhosppsych.2005.01.001. No abstract available.

    PubMed 15882761

  • Engel CC, Hyams KC, Scott K. Managing future Gulf War Syndromes: international lessons and new models of care. Philos Trans R Soc Lond B Biol Sci. 2006 Apr 29;361(1468):707-20. doi: 10.1098/rstb.2006.1829.

    PubMed 16687273

  • Spira, J.L., Pyne, J.M., & Wiederhold, B. (2006). Chapter 10: Experiential Methods in the Treatment of Combat PTSD. In Figley, C.R. and Nash, W.P. In For Those Who Bore the Battle: Combat Stress Injury Theory, Research, and Management. For the Routledge Psychosocial Stress Book Series

  • Tanielian, T. & Jaycox, L., Eds. "Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery." RAND/MG-720- CCF (available at http://veterans.rand.org)

  • Jaycox LH, Stein BD, Kataoka SH, Wong M, Fink A, Escudero P, Zaragoza C. Violence exposure, posttraumatic stress disorder, and depressive symptoms among recent immigrant schoolchildren. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1104-10. doi: 10.1097/00004583-200209000-00011.

    PubMed 12218432

  • Lisa S. Meredith, Terri L. Tanielian, Michael D. Greenberg, Ana Suárez, Elizabeth Eiseman. "Expanding Access to Mental Health Counselors: Evaluation of the Tricare Demonstration" RAND/DRR-3458-1-OSD (available at www.rand.org)

  • Stein BD, Tanielian TL, Ryan GW, Rhodes HJ, Young SD, Blanchard JC. A bitter pill to swallow: nonadherence with prophylactic antibiotics during the anthrax attacks and the role of private physicians. Biosecur Bioterror. 2004;2(3):175-85. doi: 10.1089/bsp.2004.2.175.

    PubMed 15588055

  • Meredith LS, Mendel P, Pearson M, Wu SY, Joyce G, Straus JB, Ryan G, Keeler E, Unutzer J. Implementation and maintenance of quality improvement for treating depression in primary care. Psychiatr Serv. 2006 Jan;57(1):48-55. doi: 10.1176/appi.ps.57.1.48.

    PubMed 16399962

  • Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. doi: 10.1176/appi.ajp.2007.06122057.

    PubMed 17974932

  • Williams JW Jr, Gerrity M, Holsinger T, Dobscha S, Gaynes B, Dietrich A. Systematic review of multifaceted interventions to improve depression care. Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):91-116. doi: 10.1016/j.genhosppsych.2006.12.003.

    PubMed 17336659

  • Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.

    PubMed 15229303

  • Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.

    PubMed 16507803

  • Engel CC, Oxman T, Yamamoto C, Gould D, Barry S, Stewart P, Kroenke K, Williams JW Jr, Dietrich AJ. RESPECT-Mil: feasibility of a systems-level collaborative care approach to depression and post-traumatic stress disorder in military primary care. Mil Med. 2008 Oct;173(10):935-40. doi: 10.7205/milmed.173.10.935.

    PubMed 19160608

  • Engel CC, Bray RM, Jaycox LH, Freed MC, Zatzick D, Lane ME, Brambilla D, Rae Olmsted K, Vandermaas-Peeler R, Litz B, Tanielian T, Belsher BE, Evatt DP, Novak LA, Unutzer J, Katon WJ. Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system. Contemp Clin Trials. 2014 Nov;39(2):310-9. doi: 10.1016/j.cct.2014.10.002. Epub 2014 Oct 12.

    PubMed 25311446

  • Belsher BE, Jaycox LH, Freed MC, Evatt DP, Liu X, Novak LA, Zatzick D, Bray RM, Engel CC. Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System. Med Care. 2016 Jul;54(7):706-13. doi: 10.1097/MLR.0000000000000545.

    PubMed 27111751

Questions about this trial

What is this clinical trial studying?

A study testing STEPS UP and OUC in people with Posttraumatic Stress Disorder (PTSD) and Depression, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in United States.

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 5 inclusion and 9 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Posttraumatic Diagnostic Scale (PDS) (time frame: baseline - 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492348, which also lists 20 linked publications.

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 14 Mar 2017.

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