Post-traumatic Stress Disorder Clinical Trial
Official title:
Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
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.
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