Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
Condition: Posttraumatic Stress Disorder (PTSD); Depression
MeSH terms: Depression; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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.
    

Intervention name(s): STEPS UP; OUC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The STEPS UP intervention enhances RESPECT-Mil in several ways:
Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement.
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.
Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours.
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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
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