Effectiveness of a Unified Transdiagnostic Treatment in Routine Care
Condition: Anxiety; Traumatic Stress Disorders; Depression
MeSH terms: Stress Disorders, Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to examine effectiveness and implementation for the Unified
      Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans.
    

Detailed description: 
      Anxiety and mood diagnoses are chronic and devastating with respect to costs to the
      individual and the healthcare system, and are more prevalent than any other class of
      disorders. When these disorders present concurrently, the significant public health
      implications and societal costs are intensified. Despite high rates of comorbidity and
      underlying mechanistic similarities between treatment protocols, single disorder evidence-
      based psychotherapy protocols for these disorders have traditionally been recommended to
      treat emotional disorders sequentially. Moreover, when clinicians are presented with complex
      case presentations, they are often unprepared to treat them and move away from evidence-based
      approaches, potentially increasing the burden on the mental health system. The Unified
      Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an innovative
      transdiagnostic protocol with promising evidence for successful treatment of emotional
      disorders, both for standalone and comorbid presentations, including the classification of
      not otherwise specified (NOS) disorders. To date, there have only been efficacy trials of the
      UP, which limit generalizability and do not address the larger public health impact and
      effectiveness in routine clinical care settings with both psychiatric and medical
      comorbidity. To address this critical limitation, the applicant proposes a pilot feasibility,
      acceptability, and tolerability study of the UP in patients with diverse psychiatric and
      medical comorbidity to manualized supportive therapy within a hospital. The deployment
      focused model (DFM) will inform design and statistical analyses. An additional aim includes
      determining the feasibility, acceptability, perceived fit and satisfaction of the UP in
      clinic settings through surveying and interviewing stakeholders in the system that are
      implementing the UP through the study. Consultation with stakeholders can minimize the time
      required to collect and assess fit within the larger system and, therefore, minimizes the
      time lag between science and practice in routine care settings. This study addresses an
      important public health concern by examining the effectiveness of the UP in a new population
      as a strategy for treatment of common and debilitating mental disorders in routine care
      settings. Furthermore, the proposed research aims will complement a comprehensive training
      plan to prepare the applicant to become an independent investigator with expertise in
      implementation science and effectiveness research. Results from the study will provide
      important information about whether or not this efficacious treatment can be effective,
      efficient, and ready for implementation in routine care settings in which psychiatric and
      medical comorbidity are common. This study will also serve as a model of deploying
      efficacious treatments into generalist clinics.
    

Intervention name(s): Unified protocol; Routine Care
Intervention type(s): Other; Other
Intervention description(s): This is a transdiagnostic cognitive behavioral therapy; This arm will reflect typical care received in routine mental health care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research