Primary Care Intervention Strategy for Anxiety Disorders

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.

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.

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

• 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.
• Behavioral: Treatment as Usual
  Participants in the control group will receive standard treatment from their PCP.

• Experimental: CALM Intervention
  Participants assigned to coordinated anxiety learning and management (CALM)
  Interventions:

  • Behavioral: Cognitive-behavioral therapy
  • Drug: Psychotropic medication optimization
• Active Comparator: Treatment as Usual (TAU)
  Participants assigned to TAU with their primary care provider (PCP)
  Intervention: Behavioral: Treatment as Usual

• 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. Epub 2011 Dec 13.
• 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. Epub 2011 Feb 22.
• 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.

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