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

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder (PTSD), Depression

In brief

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.

Key facts

Study ID

NCT01492348

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

666

Starts

2012-01-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Evans Army Community Hospital — Fort Carson, Colorado, United States
• Winn Army Community Hospital — Fort Stewart, Georgia, United States
• Blanchfield Army Community Hospital — Fort Campbell, Kentucky, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States
• William Beaumont Army Medical Center — Fort Bliss, Texas, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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