Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | February 2016 |
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.
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.
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.
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.
We found this trial at
6
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
Click here to add this to my saved trials