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

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.

Conditions

• Posttraumatic Stress Disorder (PTSD)
• Depression

Interventions

BEHAVIORAL

STEPS UP

The STEPS UP intervention enhances RESPECT-Mil in several ways: 1. Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement. 2. Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, \& primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist. 3. Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours. 4. Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components.

BEHAVIORAL

OUC

Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the "three-component model" where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• RAND

  collaborator OTHER

• RTI International

  collaborator OTHER

• University of Washington

  collaborator OTHER

• VA Boston Healthcare System

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Robert M Bray, PhD · RTI International

• Lisa Jaycox, PhD · RAND

• Bradley E Belsher, PhD · United States Department of Defense

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-10-31

Completion

2016-02-29

Countries

• United States

Study Locations