Primary Care Intervention Strategy for Anxiety Disorders

NCT00347269 | Completed Phase 4 Results DMC

• 3 other identifiers: 28630U01MH057858-05DSIR 83-ATAS
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Post-traumatic Stress Disorder; Generalized Anxiety Disorder; Panic Disorder; Social Anxiety Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• BSI-12 (Anxiety and Somatization Subscales)

  12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms

  Measured at Month 18

Secondary Outcomes (1)

• 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

Study Arms (2)

CALM Intervention

EXPERIMENTAL

Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization

Behavioral: Cognitive-behavioral therapy; Drug: Psychotropic medication optimization

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants assigned to TAU with their primary care provider (PCP)

Behavioral: Treatment as Usual

Interventions

Cognitive-behavioral therapy 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.

CALM Intervention

Psychotropic medication optimization 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.

Also known as: SSRI, SNRI, Benzodiazepine,

CALM Intervention

Treatment as Usual BEHAVIORAL

Participants in the control group will receive standard treatment from their PCP.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
• Speak English or Spanish (English only at UAMS site)

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72114, United States

Location

University of California

La Jolla, California, 92037-0603, United States

Location

University of California

Los Angeles, California, 90095-1563, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (35)

• 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.

  PMID: 22460001 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.

  PMID: 19632667 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.

  PMID: 19264941 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.

  PMID: 18486238 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.

  PMID: 17888803 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.

  PMID: 25272965 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.

  PMID: 24619599 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.

  PMID: 24660674 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.

  PMID: 24338947 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.

  PMID: 23801589 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.

  PMID: 23886736 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.

  PMID: 23370069 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.

  PMID: 23608160 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.

  PMID: 23750465 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.

  PMID: 23580378 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.

  PMID: 23729989 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.

  PMID: 23332608 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.

  PMID: 23407203 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.

  PMID: 23377641 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.

  PMID: 23225338 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.

  PMID: 23184657 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.

  PMID: 23290323 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.

  PMID: 22152230 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.

  PMID: 22304968 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.

  PMID: 22404963 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.

  PMID: 21762829 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.

  PMID: 21367351 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.

  PMID: 21464362 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.

  PMID: 20146834 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.

  PMID: 20483968 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.

  PMID: 19829198 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.

  PMID: 19212970 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.

  PMID: 27775823 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.

  PMID: 26563229 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.

  PMID: 25562579 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Panic Disorder; Phobia, Social; Anxiety Disorders; Stress Disorders, Traumatic

Interventions

Cognitive Behavioral Therapy; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Benzodiazepines; Therapeutics

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Peter Roy-Byrne MD Professor of Psychiatry
• Organization: University of Washington

roybyrne@u.washington.edu

206-313-8504

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Kristin Bumgardner, BS

  University of Washington

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)