Clinical trial NCT01492348: Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
Official title: Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: RAND
name: RTI International
name: University of Washington
name: VA Boston Healthcare System
First posted: 2011-12-14
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Posttraumatic Diagnostic Scale (PDS)
timeFrame: baseline - 3 months
measure: Posttraumatic Diagnostic Scale (PDS)
timeFrame: baseline - 6 months
measure: Posttraumatic Diagnostic Scale (PDS)
timeFrame: baseline - 12 months
measure: Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
timeFrame: baseline - 3 months
measure: Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
timeFrame: baseline - 6 months
measure: Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
timeFrame: baseline - 12 months
Secondary outcomes:
measure: Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
timeFrame: baseline - 3 months
measure: Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
timeFrame: baseline - 6 months
measure: Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
timeFrame: baseline - 12 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: eligibility - 3 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: eligibility - 6 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: eligibility - 12 months
measure: Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
timeFrame: baseline - 3 months
measure: Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
timeFrame: baseline - 6 months
measure: Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
timeFrame: baseline - 12 months
measure: WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)
timeFrame: baseline - 3 months
measure: WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)
timeFrame: baseline - 6 months
measure: WHO Health and Work Performance Questionnaire-Short Form (HPQ-SF)
timeFrame: baseline - 12 months
measure: Numeric Rating Scale for Pain
timeFrame: baseline - 3 months
measure: Numeric Rating Scale for Pain
timeFrame: baseline - 6 months
measure: Numeric Rating Scale for Pain
timeFrame: baseline - 12 months
Other outcomes:
Locations:
city: Ft. Carson
country: United States
facility: Evans Army Community Hospital
state: Colorado
city: Fort Stewart
country: United States
facility: Winn Army Community Hospital
state: Georgia
city: Fort Campbell
country: United States
facility: Blanchfield Army Community Hospital
state: Kentucky
city: Ft. Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: Fort Bliss
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: RTI International
name: Robert M Bray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Lisa Jaycox, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: United States Department of Defense
name: Bradley E Belsher, PhD
role: PRINCIPAL_INVESTIGATOR
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