Depression Clinical Trial
Official title:
Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
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.
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.
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