Post-traumatic Stress Disorder Clinical Trial
Official title:
Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Verified date | March 2017 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1004 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California | La Jolla | California |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | University of California | Los Angeles | California |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Mental Health (NIMH) |
United States,
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. — View Citation
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 — View Citation
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/ — View Citation
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 M — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
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. 2 — View Citation
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 — View Citation
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):71 — View Citation
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): — View Citation
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. Review. — View Citation
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. Ar — View Citation
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. — View Citation
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. do — View Citation
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 — View Citation
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. — View Citation
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. Depres — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
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 — View Citation
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 — View Citation
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.0b013e3182 — View Citation
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. — View Citation
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: 10.1 — View Citation
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: — View Citation
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. — View Citation
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 — View Citation
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. 2 — View Citation
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 — View Citation
* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of intervention as measured by the BSI-12 (anxiety and somatization subscales) | Measured at Month 18 | ||
Secondary | 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 | Measured at Month 18 |
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