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

NCT01492348 | Completed DMC

• 1 other identifier: W81XWH-09-2-0077
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 6

Brief 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. 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. 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.

Conditions

Posttraumatic Stress Disorder (PTSD); Depression

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

Outcome Measures

Primary Outcomes (6)

• 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.

  baseline - 3 months

• 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.

  baseline - 6 months

• 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.

  baseline - 12 months

• 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).

  baseline - 3 months

• 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).

  baseline - 6 months

• 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).

  baseline - 12 months

Secondary Outcomes (15)

• Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

  baseline - 3 months

• Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

  baseline - 6 months

• Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)

  baseline - 12 months

• Alcohol Use Disorders Identification Test (AUDIT)

  eligibility - 3 months

• Alcohol Use Disorders Identification Test (AUDIT)

  eligibility - 6 months

Study Arms (2)

STEPS UP Intervention

EXPERIMENTAL

STEPS 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.

Behavioral: STEPS UP

Optimized Usual Care (OUC)

ACTIVE COMPARATOR

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 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.

Behavioral: OUC

Interventions

STEPS UP BEHAVIORAL

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.

STEPS UP Intervention

OUC BEHAVIORAL

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.

Optimized Usual Care (OUC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Acute or unstable physical illness.
• Anticipated deployment, demobilization, or separation during the next six months.
• Personnel who work in participating clinics.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• United States Department of Defense: collaborator
• RAND: collaborator
• RTI International: collaborator
• University of Washington: collaborator
• VA Boston Healthcare System: collaborator

Study Sites (6)

Evans Army Community Hospital

Fort Carson, Colorado, 80913, United States

Location

Winn Army Community Hospital

Fort Stewart, Georgia, 31409-5102, United States

Location

Blanchfield Army Community Hospital

Fort Campbell, Kentucky, 42333, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

William Beaumont Army Medical Center

Fort Bliss, Texas, 79920-5001, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (20)

• 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.

  PMID: 15882761 BACKGROUND

• 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.

  PMID: 16687273 BACKGROUND

• 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

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 12218432 BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 15588055 BACKGROUND

• 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.

  PMID: 16399962 BACKGROUND

• 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.

  PMID: 17974932 BACKGROUND

• 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.

  PMID: 17336659 BACKGROUND

• 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.

  PMID: 15229303 BACKGROUND

• 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.

  PMID: 16507803 BACKGROUND

• 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.

  PMID: 19160608 BACKGROUND

• 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.

  PMID: 25311446 RESULT

• 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.

  PMID: 27111751 RESULT

• Engel CC, Jaycox LH, Freed MC, Bray RM, Brambilla D, Zatzick D, Litz B, Tanielian T, Novak LA, Lane ME, Belsher BE, Olmsted KL, Evatt DP, Vandermaas-Peeler R, Unutzer J, Katon WJ. Centrally Assisted Collaborative Telecare for Posttraumatic Stress Disorder and Depression Among Military Personnel Attending Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):948-56. doi: 10.1001/jamainternmed.2016.2402.

  PMID: 27294447 RESULT

• Tanielian T, Woldetsadik MA, Jaycox LH, Batka C, Moen S, Farmer C, Engel CC. Barriers to Engaging Service Members in Mental Health Care Within the U.S. Military Health System. Psychiatr Serv. 2016 Jul 1;67(7):718-27. doi: 10.1176/appi.ps.201500237. Epub 2016 Mar 15.

  PMID: 26975521 RESULT

• Batka C, Tanielian T, Woldetsadik MA, Farmer C, Jaycox LH. Stakeholder Experiences in a Stepped Collaborative Care Study Within U.S. Army Clinics. Psychosomatics. 2016 Nov-Dec;57(6):586-597. doi: 10.1016/j.psym.2016.05.008. Epub 2016 May 31.

  PMID: 27478057 RESULT

• Bray RM, Engel CC, Williams J, Jaycox LH, Lane ME, Morgan JK, Unutzer J. Posttraumatic Stress Disorder in U.S. Military Primary Care: Trajectories and Predictors of One-Year Prognosis. J Trauma Stress. 2016 Aug;29(4):340-8. doi: 10.1002/jts.22119. Epub 2016 Jul 22.

  PMID: 27447948 RESULT

• Belsher BE, Evatt DP, Liu X, Freed MC, Engel CC, Beech EH, Jaycox LH. Collaborative Care for Depression and Posttraumatic Stress Disorder: Evaluation of Collaborative Care Fidelity on Symptom Trajectories and Outcomes. J Gen Intern Med. 2018 Jul;33(7):1124-1130. doi: 10.1007/s11606-018-4451-5. Epub 2018 Apr 27.

  PMID: 29704183 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Robert M Bray, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Lisa Jaycox, PhD

  RAND

  PRINCIPAL INVESTIGATOR

• Bradley E Belsher, PhD

  United States Department of Defense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: December 14, 2011
• Study Start: January 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)