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

Purpose

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 depression, anxiety, and 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: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will have significantly lower direct and indirect costs of care and a more favorable cost-effectiveness ratio compared to participants assigned to OUC over 12-months of follow-up.

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.

Condition	Intervention	Phase
Posttraumatic Stress Disorder (PTSD) Depression	Behavioral: STEPS UP Behavioral: OUC	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Anxiety Depression Mental Health Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:

Posttraumatic Diagnostic Scale (PDS) [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.
Posttraumatic Diagnostic Scale (PDS) [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.
Posttraumatic Diagnostic Scale (PDS) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20) [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20) [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
The HSCL-20 is a self-report scale comprising the 13 items of the Hopkins Symptom Checklist Depression Scale plus 7 additional items from the Hopkins Symptom Checklist-90-Revised. The HSCL-20 has been widely used as an outcome measure of depressive severity in large clinical trials (Boudreau, et al., 2002; Felker, et al., 2001; Fraser, et al., 2004; Hedrick, et al., 2003; Katon, et al., 1996; Kroenke, et al., 2001; Unutzer, et al., 2002; Williams, et al., 2000).

Secondary Outcome Measures:

Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15) [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, & Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).
Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15) [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, & Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).
Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
Somatic symptom severity will be measured with the widely used and validated 15 item Patient Health Questionnaire (PHQ-15; Kroenke, Spitzer, & Williams, 2002). A total sum of greater than or equal to 15 indicate a high somatic symptom severity based on data from primary care settings (Kroenke et al., 2002).
Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: eligibility - 3 months ] [ Designated as safety issue: No ]
The AUDIT (Babor, Higgins-Biddle, Saunders, & Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, & Babor, 1997; Saunders, Aasland, Amundsen, & Grant, 1993; Saunders, Aasland, Babor, de, & Grant, 1993)
Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: eligibility - 6 months ] [ Designated as safety issue: No ]
The AUDIT (Babor, Higgins-Biddle, Saunders, & Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, & Babor, 1997; Saunders, Aasland, Amundsen, & Grant, 1993; Saunders, Aasland, Babor, de, & Grant, 1993)
Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: eligibility - 12 months ] [ Designated as safety issue: No ]
The AUDIT (Babor, Higgins-Biddle, Saunders, & Monteiro, 2001) will be used to assess alcohol use, alcohol dependence symptoms, and alcohol-related problems, focused on the recent past. This 10-item scale is widely used and has been shown to be consistent with ICD-10 definitions for alcohol dependence and harmful alcohol use (Allen, Litten, Fertig, & Babor, 1997; Saunders, Aasland, Amundsen, & Grant, 1993; Saunders, Aasland, Babor, de, & Grant, 1993)
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
Limitations in role functioning will be assessed using the SF-12 (Ware et al., 1996). The SF-12 is a widely used measure of health-related quality of life and functioning with established reliability and validity. This measure will be used for the economic analysis as well as to measure functioning as an outcome.
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF) [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF) [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
The HPQ-SF (Kessler, et al., 2004; Kessler, et al., 2003) will be used to assess work presenteeism and absenteeism. The self-report survey contains 11 items and assesses work in the prior 4 weeks. These items will be used both to assess work functioning and to estimate costs related to PTSD and associated conditions.
Numeric Rating Scale for Pain [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994). The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.
Numeric Rating Scale for Pain [ Time Frame: baseline - 6 months ] [ Designated as safety issue: No ]
This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994). The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.
Numeric Rating Scale for Pain [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
This trial will use a two-item numeric rating scale for pain, adapted from the NRS (Cleeland and Ryan, 1994). The items ask patients to rate pain intensity on average and how much the pain interferes with their daily activities on 11-point numeric rating scales.

Estimated Enrollment:	1500
Study Start Date:	January 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: STEPS UP Centralized telephonic stepped care management (STEPS UP) is designed to give service members seeking treatment in primary care access to a variety of options for addressing their mental health needs. The program provides several treatment options for service members and their health professionals to choose from. Options include telephone support, internet support, therapy, and/or medication. Care Managers (CMs) will work closely with patients and clinic-based primary and specialty care clinicians throughout implementation of each "step" of the STEPS UP treatment, serving as the "front-line" facilitator of evidence-based PTSD and depression care for the duration of the twelve month intervention.	Behavioral: STEPS UP STEP 1: Patient Engagement, Education, and Preference Development STEP 1 Care Manager (CM) activities are ongoing regardless of whether the patient steps up to a higher level of care. STEP 2: Enhanced Primary Care (PC) PTSD/Depression Treatment CMs encourage patients that remain clinically symptomatic after 3-6 wks to step up the treatment intensity. STEP 2 will include one or more of the following: Web-based therapy Telephonic therapy Medication Face-to-face therapy STEP 3: Referral to Mental Health Care Patients with PTSD/depression appropriate for STEP 3 treatment include: 1. patients that request a mental health referral; 2. complex patients; 3. patients unresponsive to STEP 1/STEP 2; 4. high risk patients; 5. patients the PC clinician is uncomfortable managing in PC. CMs insure successful transition of care to STEP 3 providers.
Active Comparator: OUC Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. Usual care is optimized by feeding back the results of eligibility, baseline, and follow-up assessments to the local provider of the patient's choice.	Behavioral: OUC Optimized usual care (OUC) at each site is RESPECT-Mil, a collaborative care model which differs from STEPS UP, but like STEPS UP, is voluntary.

Arms

Assigned Interventions

Experimental: STEPS UP

Centralized telephonic stepped care management (STEPS UP) is designed to give service members seeking treatment in primary care access to a variety of options for addressing their mental health needs. The program provides several treatment options for service members and their health professionals to choose from. Options include telephone support, internet support, therapy, and/or medication. Care Managers (CMs) will work closely with patients and clinic-based primary and specialty care clinicians throughout implementation of each "step" of the STEPS UP treatment, serving as the "front-line" facilitator of evidence-based PTSD and depression care for the duration of the twelve month intervention.

Behavioral: STEPS UP

STEP 1: Patient Engagement, Education, and Preference Development

STEP 1 Care Manager (CM) activities are ongoing regardless of whether the patient steps up to a higher level of care.

STEP 2: Enhanced Primary Care (PC) PTSD/Depression Treatment

CMs encourage patients that remain clinically symptomatic after 3-6 wks to step up the treatment intensity. STEP 2 will include one or more of the following:
1. Web-based therapy
2. Telephonic therapy
3. Medication
4. Face-to-face therapy

STEP 3: Referral to Mental Health Care

Patients with PTSD/depression appropriate for STEP 3 treatment include: 1. patients that request a mental health referral; 2. complex patients; 3. patients unresponsive to STEP 1/STEP 2; 4. high risk patients; 5. patients the PC clinician is uncomfortable managing in PC.
CMs insure successful transition of care to STEP 3 providers.

Active Comparator: OUC

Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. Usual care is optimized by feeding back the results of eligibility, baseline, and follow-up assessments to the local provider of the patient's choice.

Behavioral: OUC

Optimized usual care (OUC) at each site is RESPECT-Mil, a collaborative care model which differs from STEPS UP, but like STEPS UP, is voluntary.

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.

We propose a 6-site, two-parallel arm (N = 1,500) randomized controlled effectiveness trial with follow-up after 3, 6, and 12 months. The enhanced care intervention arm is telephone care management with a centralized stepped and preference-based management package that consists of the following evidence based interventions: 1) web based treatment for PTSD and depression; 2) telephonic cognitive behavioral treatment; 3) pharmacotherapy administered by within a primary care setting and in telephone consultation with a psychiatrist; and 4) specialty mental health referral. This STepped Enhancement of PTSD Services Using Primary Care (STEPS UP) management package will be compared to optimized usual care (OUC), a collaborative care model where psychiatric consultation is readily available within primary care clinics, called RESPECT-mil.

Primary outcomes include symptom-, health related quality of life-, and functioning-based metrics. We will also perform qualitative assessments of perceived intervention acceptability and effectiveness. We will interview patients within both arms of the randomized trial to assess patients' experience with and perceptions of centralized telephone care management and associated tools, and will also interview providers, the care managers, and administrators working with the care management capability to gain insights into whether and how the telephone care management may be facilitating their care and management of their patients with war-related PTSD and/or depression. Lastly, we will assess the incremental cost-effectiveness of STEPS UP over OUC.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active duty status at the time of enrollment
Positive PTSD screen (2 or more yes responses on PC-PTSD (reference), per routine primary care screening.
DSM-IV-TR 21 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 provides 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 or medical record review 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 or medical record review within the past 12 months.
Active suicidal ideation within the past 2 months by history or medical record review.
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 based on the judgment of the patient's primary care clinician.
Anticipated deployment, demobilization, or separation during the next six months.
Personnel who work in participating clinics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492348

Contacts

Contact: Michael C Freed, PhD	301-295-7350	michael.c.freed.ctr@health.mil
Contact: Laura Novak	301-295-7495	laura.a.novak.ctr@health.mil

Locations

United States, Colorado
Evans Army Community Hospital	Recruiting
Ft. Carson, Colorado, United States, 80913
Contact: LTC Robert C Price, MD 719-503-7202 robert.c.price@amedd.army.mil
Contact: Tahlia Bragg 719-503-7262 tbragg@stu.rti.org
United States, Georgia
Winn Army Community Hospital	Recruiting
Fort Stewart, Georgia, United States, 31409-5102
Contact: Allen Swan, MD 912-656-7350 allen.swan@amedd.army.mil
Contact: Alison Campbell 912-704-5852 acambell@stu.rti.org
United States, Kentucky
Blanchfield Army Community Hospital	Recruiting
Fort Campbell, Kentucky, United States, 42333
Contact: Lisa Ford, FNP-BC 270-461-4638 lisa.r.ford@amedd.army.mil
Contact: Sarah Nelson 270-412-3778 snelson@stu.rti.org
United States, North Carolina
Womack Army Medical Center	Not yet recruiting
Ft. Bragg, North Carolina, United States, 28310
Contact: MAJ Thurman Saunders, MSN, FNP-C 910-570-3081 thurman.saunders@us.army.mil
Contact: Carol Sheff 915-207-6787 csheff@stu.rti.org
United States, Texas
William Beaumont Army Medical Center	Recruiting
Fort Bliss, Texas, United States, 79920-5001
Contact: Melissa Molina, MD 915-742-1643 melissa.molina3@us.army.mil
Contact: Laura Whitton Bonnett 915-742-1263 lbonnet@stu.rti.org
United States, Washington
Madigan Army Medical Center	Recruiting
Tacoma, Washington, United States, 98431
Contact: Burton Kerr, PhD 253-968-4846 Burton.Kerr@us.army.mil
Contact: Christian Geye, MA 253-968-4531 cgeye@rti.org

Sponsors and Collaborators

Henry M. Jackson Foundation for the Advancement of Military Medicine

Department of Defense

RAND

RTI International

Investigators

Principal Investigator:	Charles C Engel, MD, MPH	Walter Reed National Military Medical Center/Uniformed Services University of the Health Sciences
Principal Investigator:	Robert M Bray, PhD	RTI International
Principal Investigator:	Lisa Jaycox, PhD	RAND Corporation
Study Director:	Michael C. Freed, PhD	Walter Reed National Military Medical Center/Uniformed Services University of the Health Sciences

More Information

Publications:

Engel CC. Improving primary care for military personnel and veterans with posttraumatic stress disorder--the road ahead. Gen Hosp Psychiatry. 2005 May-Jun;27(3):158-60. No abstract available.

Engel CC, Hyams KC, Scott K. Managing future Gulf War Syndromes: international lessons and new models of care. Philos Trans R Soc Lond B Biol Sci. 2006 Apr 29;361(1468):707-20.

Jaycox LH, Stein BD, Kataoka SH, Wong M, Fink A, Escudero P, Zaragoza C. Violence exposure, posttraumatic stress disorder, and depressive symptoms among recent immigrant schoolchildren. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1104-10.

Meredith LS, Mendel P, Pearson M, Wu SY, Joyce G, Straus JB, Ryan G, Keeler E, Unützer J. Implementation and maintenance of quality improvement for treating depression in primary care. Psychiatr Serv. 2006 Jan;57(1):48-55.

Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83.

Williams JW Jr, Gerrity M, Holsinger T, Dobscha S, Gaynes B, Dietrich A. Systematic review of multifaceted interventions to improve depression care. Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):91-116. Review.

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22.

Responsible Party:	Charles Engel, Dir., Deployment Health Clinical Center, WRNMMC; Associate Professor of Psychiatry, USUHS, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:	NCT01492348 History of Changes
Other Study ID Numbers:	W81XWH-09-2-0077
Study First Received:	March 31, 2010
Last Updated:	March 19, 2013
Health Authority:	United States: Federal Government

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

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

Additional relevant MeSH terms:

Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on June 18, 2013