Primary Care Intervention Strategy for Anxiety Disorders
Condition: Post-traumatic Stress Disorder; Generalized Anxiety Disorder; Panic Disorder; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Panic Disorder; Phobia, Social
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Cognitive-behavioral therapy; Psychotropic medication optimization; Treatment as Usual
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): 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.; 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.; Participants in the control group will receive standard treatment from their PCP.
Other intervention name(s): SSRI, SNRI, Benzodiazepine,
Intervention MeSH terms: Psychotropic Drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
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