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Primary Care Intervention Strategy for Anxiety Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347269
First Posted: July 4, 2006
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington
  Purpose
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.

Condition Intervention Phase
Post-traumatic Stress Disorder Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder Behavioral: Cognitive-behavioral therapy Drug: Psychotropic medication optimization Behavioral: Treatment as Usual Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes

Resource links provided by NLM:


Further study details as provided by Peter Roy-Byrne, University of Washington:

Primary Outcome Measures:
  • BSI-12 (Anxiety and Somatization Subscales) [ Time Frame: Measured at Month 18 ]
    12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms


Secondary Outcome Measures:
  • Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9 [ Time Frame: Measured at Month 18 ]

Enrollment: 1004
Study Start Date: June 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CALM Intervention

Participant choice of:

Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization

Behavioral: 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.
Drug: 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.
Other Name: SSRI, SNRI, Benzodiazepine,
Active Comparator: Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP)
Behavioral: Treatment as Usual
Participants in the control group will receive standard treatment from their PCP.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347269


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72114
United States, California
University of California
La Jolla, California, United States, 92037-0603
University of California
Los Angeles, California, United States, 90095-1563
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Peter P. Roy-Byrne, MD University of Washington
Principal Investigator: Cathy D. Sherbourne, PhD RAND Corporation, Santa Monica, CA
Principal Investigator: Michelle G. Craske, PhD University of California, Los Angeles
Principal Investigator: Greer Sullivan, MD, MSPH University of Arkansas for Medical Sciences, Little Rock, AR
Principal Investigator: Murray B. Stein, MD, MPH University of California, San Diego, San Diego, CA
Study Director: Kristin Bumgardner, BS University of Washington
  More Information

Publications:
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.
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.
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.
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.
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.
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.
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.
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.
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):639-49. doi: 10.1037/a0033403. Epub 2013 Jun 10.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Review.
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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Roy-Byrne, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00347269     History of Changes
Other Study ID Numbers: 28630
U01MH057858-05 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS ( Other Identifier: NIMH Program Class Code )
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: April 8, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Limited access datasets are available through the National Database for Clinical Trials Related to Mental Illness (NDCT), part of the NIMH Data Archive: https://data-archive.nimh.nih.gov/ndct/.

Keywords provided by Peter Roy-Byrne, University of Washington:
Anxiety Disorders
Post-traumatic Stress Disorder
Generalized Anxiety Disorder
Panic Disorder
Social Anxiety Disorder
Stress
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Mental Health Disorders

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Panic Disorder
Phobic Disorders
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Psychotropic Drugs


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