Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care

Conditions
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Anxiety, Traumatic Stress Disorders, Depression

Intervention / Treatment
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* Other: Unified protocol
* Other: Routine Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Veteran Participants: VA Boston Health Care Patient: Definition: Currently enrolled as a patient at VA Boston Healthcare System Diagnosis of an emotional disorder Definition: Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of any emotional disorder (anxiety disorder, traumatic stress disorders, or unipolar depression) Cognitive Functioning: Definition: free of cognitive impairment demonstrated by ability to understand and provide consent Psychotherapy: Definition: not currently in psychotherapy for an emotional disorder treated in the study Stakeholder Inclusion Criteria Provider Status: Definition: Providing or overseeing mental health treatment in VA Boston Healthcare System and VA Puget Sound Healthcare System Exclusion Criteria: Veteran Participant Exclusionary Criteria Current diagnosis of substance dependence (but not abuse) Primary diagnosis of bipolar disorder Current diagnosis of psychosis High suicidal risk (plan with intent) Recent change in psychiatric medications (< 3 months prior to entering the study).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol<br>Unified Protocol-psychotherapy | Other: Unified protocol<br>* This is a transdiagnostic cognitive behavioral therapy<br>|
| Experimental: Routine Care<br>Routine Care psychotherapy comparison | Other: Routine Care<br>* This arm will reflect typical care received in routine mental health care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR) | These interviews will occur at one time point and will be analyzed with Qualitative Comparative Analyses guided by the Consolidated Framework for Implementation Research. Qualitative analyses are often descriptive in nature and a summary of common themes are reported to speak to factors impacting implementation of the intervention in this population. NVivo software will be used to aggregate the qualitative interviews from all participants and highlight the common themes across CFIR interviews | One time assessment, occurring on 1 day, approximately 4 months after treatment initiation | 
| Change in clinician administered Anxiety Disorders Interview Scheduled will be used to generate clinical diagnoses for mental health disorders | Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting clinician severity rating for each mental health diagnosis. This assessment will be used in conjunction with the CAPS-5 (outcome 3) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis | 7 months | 
| Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to asses the presence or absence of a clinical diagnosis of PTSD | Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting severity rating for a PTSD diagnosis. This assessment will be used in conjunction with the ADIS-5 (outcome 2) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis. They cannot be combine into one variable unless a dichotomous score is calculated to indicate a clinical diagnosis more broadly is present versus absent. | 7 months |