Primary Care Intervention Strategy for Anxiety Disorders
NCT ID: NCT00347269
Last Updated: 2017-05-19
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
1004 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-06-30
Study Completion Date
2009-10-31
Brief Summary
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This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.
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Detailed Description
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Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manager assisted chronic disease management program for four common anxiety disorders (post-traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder) in the primary care setting. This approach has been shown to be effective for the treatment of depression.
Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
Conditions
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Post-traumatic Stress Disorder
Generalized Anxiety Disorder
Panic Disorder
Social Anxiety Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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CALM Intervention
Participant choice of:
Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
Group Type
EXPERIMENTAL
Cognitive-behavioral therapy
Intervention Type
BEHAVIORAL
Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization
Intervention Type
DRUG
For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP)
Group Type
ACTIVE_COMPARATOR
Treatment as Usual
Intervention Type
BEHAVIORAL
Participants in the control group will receive standard treatment from their PCP.
Interventions
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Cognitive-behavioral therapy
Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Intervention Type
BEHAVIORAL
Psychotropic medication optimization
For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
Intervention Type
DRUG
Treatment as Usual
Participants in the control group will receive standard treatment from their PCP.
Intervention Type
BEHAVIORAL
Other Intervention Names
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SSRI, SNRI, Benzodiazepine,
Eligibility Criteria
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Inclusion Criteria
* MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
* Speak English or Spanish (English only at UAMS site)
* Speak English or Spanish (English only at UAMS site)
Exclusion Criteria
* Diagnosis of Bipolar 1
* Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol
* Acute suicidality or homicidality
Eligible subjects must be current patients at one of the participating primary care clinics which include:
University of Washington:
* Harborview's Adult Medicine Clinic
* Harborview's Family Medicine Clinic
* UWMC's General Internal Medicine Clinic at Roosevelt Clinic
* PSNHC's 45th Street Clinic
* Country Doctor Community Clinic
* Carolyn Downs Family Medical Center
UCLA:
* Desert Medical Group, Palm Springs CA
* High Desert Medical Group, Lancaster, CA
UCSD:
* Kaiser Permanente, Bonita Medical Offices
* Kaiser Permanente, Otay Mesa Outpatient Medical Center
* UCSD Medical Center, Scripps Ranch Medical Office
* UCSD Medical Center, Fourth and Lewis Medical Office
* UCSD Medical Center, Perlman Ambulatory Care Center
* Sharp Rees-Stealy Medical Group, El Cajon
* Sharp Rees-Stealy Medical Group, Mira Mesa
UAMS:
* UAMS UPMG
* Little Rock Diagnostic Clinic
* St. Vincent's Family Clinic South
* Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol
* Acute suicidality or homicidality
Eligible subjects must be current patients at one of the participating primary care clinics which include:
University of Washington:
* Harborview's Adult Medicine Clinic
* Harborview's Family Medicine Clinic
* UWMC's General Internal Medicine Clinic at Roosevelt Clinic
* PSNHC's 45th Street Clinic
* Country Doctor Community Clinic
* Carolyn Downs Family Medical Center
UCLA:
* Desert Medical Group, Palm Springs CA
* High Desert Medical Group, Lancaster, CA
UCSD:
* Kaiser Permanente, Bonita Medical Offices
* Kaiser Permanente, Otay Mesa Outpatient Medical Center
* UCSD Medical Center, Scripps Ranch Medical Office
* UCSD Medical Center, Fourth and Lewis Medical Office
* UCSD Medical Center, Perlman Ambulatory Care Center
* Sharp Rees-Stealy Medical Group, El Cajon
* Sharp Rees-Stealy Medical Group, Mira Mesa
UAMS:
* UAMS UPMG
* Little Rock Diagnostic Clinic
* St. Vincent's Family Clinic South
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
University of Washington
OTHER
Sponsor Role
lead
Responsible Party
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Peter Roy-Byrne
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Peter P. Roy-Byrne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Cathy D. Sherbourne, PhD
Role: PRINCIPAL_INVESTIGATOR
RAND Corporation, Santa Monica, CA
Michelle G. Craske, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Greer Sullivan, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas for Medical Sciences, Little Rock, AR
Murray B. Stein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego, San Diego, CA
Kristin Bumgardner, BS
Role: STUDY_DIRECTOR
University of Washington
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Site Status
University of California
La Jolla, California, United States
Site Status
University of California
Los Angeles, California, United States
Site Status
University of Washington
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Lang AJ, Wilkins K, Roy-Byrne PP, Golinelli D, Chavira D, Sherbourne C, Rose RD, Bystritsky A, Sullivan G, Craske MG, Stein MB. Abbreviated PTSD Checklist (PCL) as a guide to clinical response. Gen Hosp Psychiatry. 2012 Jul-Aug;34(4):332-8. doi: 10.1016/j.genhosppsych.2012.02.003. Epub 2012 Mar 27.
Reference Type
BACKGROUND
Craske MG, Roy-Byrne PP, Stein MB, Sullivan G, Sherbourne C, Bystritsky A. Treatment for anxiety disorders: Efficacy to effectiveness to implementation. Behav Res Ther. 2009 Nov;47(11):931-7. doi: 10.1016/j.brat.2009.07.012. Epub 2009 Jul 14.
Reference Type
BACKGROUND
Roy-Byrne P, Veitengruber JP, Bystritsky A, Edlund MJ, Sullivan G, Craske MG, Welch SS, Rose R, Stein MB. Brief intervention for anxiety in primary care patients. J Am Board Fam Med. 2009 Mar-Apr;22(2):175-86. doi: 10.3122/jabfm.2009.02.080078.
Reference Type
BACKGROUND
Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.
Reference Type
BACKGROUND
Sullivan G, Craske MG, Sherbourne C, Edlund MJ, Rose RD, Golinelli D, Chavira DA, Bystritsky A, Stein MB, Roy-Byrne PP. Design of the Coordinated Anxiety Learning and Management (CALM) study: innovations in collaborative care for anxiety disorders. Gen Hosp Psychiatry. 2007 Sep-Oct;29(5):379-87. doi: 10.1016/j.genhosppsych.2007.04.005.
Reference Type
BACKGROUND
Brown LA, Krull JL, Roy-Byrne P, Sherbourne CD, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. An examination of the bidirectional relationship between functioning and symptom levels in patients with anxiety disorders in the CALM study. Psychol Med. 2015 Feb;45(3):647-61. doi: 10.1017/S0033291714002062. Epub 2014 Oct 2.
Reference Type
RESULT
Brown LA, Wiley JF, Wolitzky-Taylor K, Roy-Byrne P, Sherbourne C, Stein MB, Sullivan G, Rose RD, Bystritsky A, Craske MG. Changes in self-efficacy and outcome expectancy as predictors of anxiety outcomes from the CALM study. Depress Anxiety. 2014 Aug;31(8):678-89. doi: 10.1002/da.22256. Epub 2014 Mar 11.
Reference Type
RESULT
Chavira DA, Golinelli D, Sherbourne C, Stein MB, Sullivan G, Bystritsky A, Rose RD, Lang AJ, Campbell-Sills L, Welch S, Bumgardner K, Glenn D, Barrios V, Roy-Byrne P, Craske M. Treatment engagement and response to CBT among Latinos with anxiety disorders in primary care. J Consult Clin Psychol. 2014 Jun;82(3):392-403. doi: 10.1037/a0036365. Epub 2014 Mar 24.
Reference Type
RESULT
Dour HJ, Wiley JF, Roy-Byrne P, Stein MB, Sullivan G, Sherbourne CD, Bystritsky A, Rose RD, Craske MG. Perceived social support mediates anxiety and depressive symptom changes following primary care intervention. Depress Anxiety. 2014 May;31(5):436-42. doi: 10.1002/da.22216. Epub 2013 Dec 12.
Reference Type
RESULT
Joesch JM, Golinelli D, Sherbourne CD, Sullivan G, Stein MB, Craske MG, Roy-Byrne PP. Trajectories of change in anxiety severity and impairment during and after treatment with evidence-based treatment for multiple anxiety disorders in primary care. Depress Anxiety. 2013 Nov;30(11):1099-106. doi: 10.1002/da.22149. Epub 2013 Jun 25.
Reference Type
RESULT
Campbell-Sills L, Stein MB, Sherbourne CD, Craske MG, Sullivan G, Golinelli D, Lang AJ, Chavira DA, Bystritsky A, Rose RD, Welch SS, Kallenberg GA, Roy-Byrne P. Effects of medical comorbidity on anxiety treatment outcomes in primary care. Psychosom Med. 2013 Oct;75(8):713-20. doi: 10.1097/PSY.0b013e31829def54. Epub 2013 Jul 25.
Reference Type
RESULT
Roy-Byrne P, Sullivan MD, Sherbourne CD, Golinelli D, Craske MG, Sullivan G, Stein MB. Effects of pain and prescription opioid use on outcomes in a collaborative care intervention for anxiety. Clin J Pain. 2013 Sep;29(9):800-6. doi: 10.1097/AJP.0b013e318278d475.
Reference Type
RESULT
Bomyea J, Lang AJ, Craske MG, Chavira D, Sherbourne CD, Rose RD, Golinelli D, Campbell-Sills L, Welch SS, Sullivan G, Bystritsky A, Roy-Byrne P, Stein MB. Suicidal ideation and risk factors in primary care patients with anxiety disorders. Psychiatry Res. 2013 Aug 30;209(1):60-5. doi: 10.1016/j.psychres.2013.03.017. Epub 2013 Apr 19.
Reference Type
RESULT
Glenn D, Golinelli D, Rose RD, Roy-Byrne P, Stein MB, Sullivan G, Bystritksy A, Sherbourne C, Craske MG. Who gets the most out of cognitive behavioral therapy for anxiety disorders? The role of treatment dose and patient engagement. J Consult Clin Psychol. 2013 Aug;81(4):639-649. doi: 10.1037/a0033403. Epub 2013 Jun 10.
Reference Type
RESULT
Wetherell JL, Petkus AJ, Thorp SR, Stein MB, Chavira DA, Campbell-Sills L, Craske MG, Sherbourne C, Bystritsky A, Sullivan G, Roy-Byrne P. Age differences in treatment response to a collaborative care intervention for anxiety disorders. Br J Psychiatry. 2013 Jul;203(1):65-72. doi: 10.1192/bjp.bp.112.118547. Epub 2013 Apr 11.
Reference Type
RESULT
Bomyea J, Lang AJ, Golinelli D, Craske MG, Chavira DA, Sherbourne CD, Rose RD, Campbell-Sills L, Welch SS, Sullivan G, Bystritsky A, Roy-Byrne P, Stein MB. Trauma Exposure in Anxious Primary Care Patients. J Psychopathol Behav Assess. 2013 Jun 1;35(2):254-263. doi: 10.1007/s10862-012-9327-0.
Reference Type
RESULT
Niles AN, Sherbourne CD, Roy-Byrne PP, Stein MB, Sullivan G, Bystritsky A, Craske MG. Anxiety treatment improves physical functioning with oblique scoring of the SF-12 short form health survey. Gen Hosp Psychiatry. 2013 May-Jun;35(3):291-6. doi: 10.1016/j.genhosppsych.2012.12.004. Epub 2013 Jan 16.
Reference Type
RESULT
Hunt J, Sullivan G, Chavira DA, Stein MB, Craske MG, Golinelli D, Roy-Byrne PP, Sherbourne CD. Race and beliefs about mental health treatment among anxious primary care patients. J Nerv Ment Dis. 2013 Mar;201(3):188-95. doi: 10.1097/NMD.0b013e3182845ad8.
Reference Type
RESULT
Sullivan G, Sherbourne C, Chavira DA, Craske MG, Gollineli D, Han X, Rose RD, Bystritsky A, Stein MB, Roy-Byrne P. Does a quality improvement intervention for anxiety result in differential outcomes for lower-income patients? Am J Psychiatry. 2013 Feb;170(2):218-25. doi: 10.1176/appi.ajp.2012.12030375.
Reference Type
RESULT
Brown LA, Craske MG, Glenn DE, Stein MB, Sullivan G, Sherbourne C, Bystritsky A, Welch SS, Campbell-Sills L, Lang A, Roy-Byrne P, Rose RD. CBT competence in novice therapists improves anxiety outcomes. Depress Anxiety. 2013 Feb;30(2):97-115. doi: 10.1002/da.22027. Epub 2012 Dec 5.
Reference Type
RESULT
Zbozinek TD, Rose RD, Wolitzky-Taylor KB, Sherbourne C, Sullivan G, Stein MB, Roy-Byrne PP, Craske MG. Diagnostic overlap of generalized anxiety disorder and major depressive disorder in a primary care sample. Depress Anxiety. 2012 Dec;29(12):1065-71. doi: 10.1002/da.22026. Epub 2012 Nov 26.
Reference Type
RESULT
Campbell-Sills L, Sherbourne CD, Roy-Byrne P, Craske MG, Sullivan G, Bystritsky A, Lang AJ, Chavira DA, Rose RD, Shaw Welch S, Stein MB. Effects of co-occurring depression on treatment for anxiety disorders: analysis of outcomes from a large primary care effectiveness trial. J Clin Psychiatry. 2012 Dec;73(12):1509-16. doi: 10.4088/JCP.12m07955.
Reference Type
RESULT
Joesch JM, Sherbourne CD, Sullivan G, Stein MB, Craske MG, Roy-Byrne P. Incremental benefits and cost of coordinated anxiety learning and management for anxiety treatment in primary care. Psychol Med. 2012 Sep;42(9):1937-48. doi: 10.1017/S0033291711002893. Epub 2011 Dec 13.
Reference Type
RESULT
Bystritsky A, Hovav S, Sherbourne C, Stein MB, Rose RD, Campbell-Sills L, Golinelli D, Sullivan G, Craske MG, Roy-Byrne PP. Use of complementary and alternative medicine in a large sample of anxiety patients. Psychosomatics. 2012 May-Jun;53(3):266-72. doi: 10.1016/j.psym.2011.11.009. Epub 2012 Feb 1.
Reference Type
RESULT
Curran GM, Sullivan G, Mendel P, Craske MG, Sherbourne CD, Stein MB, McDaniel A, Roy-Byrne P. Implementation of the CALM intervention for anxiety disorders: a qualitative study. Implement Sci. 2012 Mar 9;7:1-11. doi: 10.1186/1748-5908-7-14.
Reference Type
RESULT
Rose RD, Lang AJ, Welch SS, Campbell-Sills L, Chavira DA, Sullivan G, Sherbourne C, Bystritsky A, Stein MB, Roy-Byrne PP, Craske MG. Training primary care staff to deliver a computer-assisted cognitive-behavioral therapy program for anxiety disorders. Gen Hosp Psychiatry. 2011 Jul-Aug;33(4):336-42. doi: 10.1016/j.genhosppsych.2011.04.011. Epub 2011 Jun 8.
Reference Type
RESULT
Stein MB, Roy-Byrne PP, Craske MG, Campbell-Sills L, Lang AJ, Golinelli D, Rose RD, Bystritsky A, Sullivan G, Sherbourne CD. Quality of and patient satisfaction with primary health care for anxiety disorders. J Clin Psychiatry. 2011 Jul;72(7):970-6. doi: 10.4088/JCP.09m05626blu. Epub 2011 Feb 22.
Reference Type
RESULT
Craske MG, Stein MB, Sullivan G, Sherbourne C, Bystritsky A, Rose RD, Lang AJ, Welch S, Campbell-Sills L, Golinelli D, Roy-Byrne P. Disorder-specific impact of coordinated anxiety learning and management treatment for anxiety disorders in primary care. Arch Gen Psychiatry. 2011 Apr;68(4):378-88. doi: 10.1001/archgenpsychiatry.2011.25.
Reference Type
RESULT
Sherbourne CD, Sullivan G, Craske MG, Roy-Byrne P, Golinelli D, Rose RD, Chavira DA, Bystritsky A, Stein MB. Functioning and disability levels in primary care out-patients with one or more anxiety disorders. Psychol Med. 2010 Dec;40(12):2059-68. doi: 10.1017/S0033291710000176. Epub 2010 Feb 11.
Reference Type
RESULT
Roy-Byrne P, Craske MG, Sullivan G, Rose RD, Edlund MJ, Lang AJ, Bystritsky A, Welch SS, Chavira DA, Golinelli D, Campbell-Sills L, Sherbourne CD, Stein MB. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. JAMA. 2010 May 19;303(19):1921-8. doi: 10.1001/jama.2010.608.
Reference Type
RESULT
Chavira DA, Stein MB, Golinelli D, Sherbourne CD, Craske MG, Sullivan G, Bystritsky A, Roy-Byrne PP. Predictors of clinical improvement in a randomized effectiveness trial for primary care patients with panic disorder. J Nerv Ment Dis. 2009 Oct;197(10):715-21. doi: 10.1097/NMD.0b013e3181b97d4d.
Reference Type
RESULT
Craske MG, Rose RD, Lang A, Welch SS, Campbell-Sills L, Sullivan G, Sherbourne C, Bystritsky A, Stein MB, Roy-Byrne PP. Computer-assisted delivery of cognitive behavioral therapy for anxiety disorders in primary-care settings. Depress Anxiety. 2009;26(3):235-42. doi: 10.1002/da.20542.
Reference Type
RESULT
Campbell-Sills L, Roy-Byrne PP, Craske MG, Bystritsky A, Sullivan G, Stein MB. Improving outcomes for patients with medication-resistant anxiety: effects of collaborative care with cognitive behavioral therapy. Depress Anxiety. 2016 Dec;33(12):1099-1106. doi: 10.1002/da.22574. Epub 2016 Oct 24.
Reference Type
DERIVED
Jakubovski E, Bloch MH. Anxiety Disorder-Specific Predictors of Treatment Outcome in the Coordinated Anxiety Learning and Management (CALM) Trial. Psychiatr Q. 2016 Sep;87(3):445-64. doi: 10.1007/s11126-015-9399-6.
Reference Type
DERIVED
Kelly JM, Jakubovski E, Bloch MH. Prognostic subgroups for remission and response in the Coordinated Anxiety Learning and Management (CALM) trial. J Clin Psychiatry. 2015 Mar;76(3):267-78. doi: 10.4088/JCP.13m08922.
Reference Type
DERIVED
Other Identifiers
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DSIR 83-ATAS
Identifier Type: OTHER
Identifier Source: secondary_id
28630
Identifier Type: -
Identifier Source: org_study_id
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