NCT02944994

Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety
• Traumatic Stress Disorders
• Depression

Interventions

Type	Name	Description
OTHER	Unified protocol	This is a transdiagnostic cognitive behavioral therapy
OTHER	Routine Care	This arm will reflect typical care received in routine mental health care

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-02-12
• Completion: 2019-02-12
• First posted: 2016-10-26
• Last updated: 2019-08-14

Locations

1 site across 1 country: United States