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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
RAND
RTI International
Information provided by (Responsible Party):
Michael Freed, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01492348
First received: March 31, 2010
Last updated: April 1, 2014
Last verified: April 2014
  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 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.


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:


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.


Enrollment: 666
Study Start Date: January 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (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:

    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 = 666) 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

Locations
United States, Colorado
Evans Army Community Hospital
Ft. Carson, Colorado, United States, 80913
United States, Georgia
Winn Army Community Hospital
Fort Stewart, Georgia, United States, 31409-5102
United States, Kentucky
Blanchfield Army Community Hospital
Fort Campbell, Kentucky, United States, 42333
United States, North Carolina
Womack Army Medical Center
Ft. Bragg, North Carolina, United States, 28310
United States, Texas
William Beaumont Army Medical Center
Fort Bliss, Texas, United States, 79920-5001
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
RAND
RTI International
Investigators
Principal Investigator: Robert M Bray, PhD RTI International
Principal Investigator: Lisa Jaycox, PhD RAND Corporation
Principal Investigator: Michael C. Freed, PhD Walter Reed National Military Medical Center/Uniformed Services University of the Health Sciences/Henry M. Jackson Foundation for the Advancement of Military Medicine
  More Information

Publications:
Responsible Party: Michael Freed, Assoc. Dir., Research, Deployment Health Clinical Center, WRNMMC; Associate Professor of Psychiatry, USUHS, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01492348     History of Changes
Other Study ID Numbers: W81XWH-09-2-0077
Study First Received: March 31, 2010
Last Updated: April 1, 2014
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 April 15, 2014