Design of the Coordinated Anxiety Learning and Management (CALM) study: innovations in collabor.....IntroductionMethodsStudy sampleStudy designClinicsAnxiety clinical specialists (ACSs)Subject referral and recruitmentSubject eligibilityRandomizationIntervention designComputer-assisted CBTPharmacotherapyTraining anxiety clinical specialistsWeb-based tracking systemAssessments and data analysisConclusionsAcknowledgmentsReferencesPsychiatry and Primary CareRecent epidemiologic studies have found that most patients with mental illness are seen exclusively in primary care medicine. These patients often presentwith medically unexplained somatic symptoms and utilize at least twice as many health care visits as controls. There has been an exponential growth in studiesin this interface between primary care and psychiatry in the last 10 years. This special section, edited by Jürgen Unutzer, M.D., will publish informativeresearch articles that address primary care-psychiatric issues.Design of the Coordinated Anxiety Learning and Management (CALM)study: innovations in collaborative care for anxiety disordersGreer Sullivan, M.D., M.S.P.H.a,b,d,⁎, Michelle G. Craske, Ph.D.c, Cathy Sherbourne, Ph.D.d,Mark J. Edlund, M.D., Ph.D.b, Raphael D. Rose, Ph.D.c, Daniela Golinelli, Ph.D.d,Denise A. Chavira, Ph.D.e, Alexander Bystritsky, M.D., Ph.D.f,Murray B. Stein, M.D., M.P.H.e,g,h, Peter P. Roy-Byrne, M.D.iaSouth Central VA Mental Illness Research Education and Clinical Center, Central Arkansas Veterans Healthcare System,North Little Rock, AR 72214-1706, USAbDepartment of Psychiatry, Division of Health Services Research, University of Arkansas for Medical Sciences, Little Rock, AR 72204-1773, USAcDepartment of Psychology, University of California, Los Angeles, CA 90095-1563, USAdHealth Program, RAND Corporation, Santa Monica, CA 90407-2138, USAeDepartment of Psychiatry, University of California, La Jolla, CA 92093-0603, USAfDepartment of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095-1759, USAgDepartment of Family and Preventive Medicine, University of California, La Jolla, CA 90093-0628, USAhPTSD Treatment Program, Psychiatry Service, VA San Diego Healthcare System, San Diego, CA 92108, USAiDepartment of Psychiatry and Behavioral Sciences, University of Washington at Harborview Medical Center, Seattle, WA 98104, USAReceived 12 February 2007; accepted 24 April 2007AbstractBackground: Despite a marked increase in the number of persons seeking help for anxiety disorders, the care provided may not be evidencebased, especially when delivered by nonspecialists. Since anxiety disorders are most often treated in primary care, quality improvementinterventions, such as the Coordinated Anxiety Learning and Management (CALM) intervention, are needed in primary care.Research Design: This study is a randomized controlled trial of a collaborative care effectiveness intervention for anxiety disorders.Subjects: Approximately 1040 adult primary care patients with at least one of four anxiety disorders (generalized anxiety disorder, panicdisorder, posttraumatic stress disorder or social anxiety disorder) will be recruited from four national sites.Intervention: Anxiety clinical specialists (ACSs) deliver education and behavioral activation to intervention patients and monitor theirsymptoms. Intervention patients choose cognitive–behavioral therapy, antianxiety medications or both in “stepped-care” treatment, whichvaries according to clinical needs. Control patients receive usual care from their primary care clinician. The innovations of CALM include thefollowing: flexibility to treat any one of the four anxiety disorders, co-occurring depression, alcohol abuse or both; use of on-site clinicians toconduct initial assessments; and computer-assisted psychotherapy delivery.Evaluation: Anxiety symptoms, functioning, satisfaction with care and health care utilization are assessed at 6-month intervals for 18 months.Conclusion: CALM was designed for clinical effectiveness and easy dissemination in a variety of primary care settings.© 2007 Elsevier Inc. All rights reserved.Keywords: Anxiety disorders; Primary care; Interventions; Collaborative care; Cognitive–behavioral therapy1. IntroductionAbout 11% of the US population will suffer from ananxiety disorder each year, and almost 29% will experiencean anxiety disorder at some p oint in their lives [1]. DespiteGeneral Hospital Psychiatry 29 (2007) 379 – 387⁎Corresponding author. North Little Rock, AR 72114, USA. Tel.: +1501 257 1713; fax: +1 501 257 1718.E-mail address: [email protected] (G. Sullivan).0163-8343/$ – see front matter © 2007 Elsevier Inc. All rights reserved.doi:10.1016/j.genhosppsych.2007.04.005a marked increase in the proportion of individualsseeking help for anxiety disorders in the last 10 years [2],their care may not be evidence based, especially whenprovided by nonspecialists [3]. Since person s with anxietydisorders are most often treated in primary care settings,quality improvement interventions within those settingsare needed.One approach to improvin g mental health care inprimary care settings is the “collaborative care” model[4–7], which is closely patterned on the “chronic diseasemodel” [8]. Various forms of the collaborative care modelhave been tested, but some featu res are common to all[9–12]. Patients typically rema in under the care of theirprimary care provider, who is assisted by a care manager,usually a master's-level clinician (e.g., nurse, socialworker), working in consultation with a psychiatrist. Inaddition to expert consult ation an d care managers,collaborative care interventions contain other componentsthat are useful in chronic disease management, includingtechniques to help patients manage their condition (patienteducation, psychotherapy, motivational enhancement andapproaches to identifying and reducing treatment barriers)and ongoing clinical monitoring of outcomes. Collaborativecare interventions are “bundles” of practices that contributeto overall care delivery. These interventions have recentlybecome more flexible by allowing patients a choice oftreatments [13].Most studies on collaborative care have been designedto assist primary care physicians in treating depression[11–14]. O ur prev ious work Collaborative Care forAnxiety and Panic is one example of a collaborative careintervention for panic disorder (PD) [15]. Similar work hastested collaborative