Effectiveness of a Unified Transdiagnostic Treatment in Routine Care



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 100
Updated:10/3/2018
Start Date:December 2014
End Date:October 2019
Contact:Caroline Canale, MPH
Email:caroline.canale@va.gov
Phone:857-364-3206

Use our guide to learn which trials are right for you!

Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care

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.

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.

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).
We found this trial at
1
site
Boston, Massachusetts 02130
Phone: 857-364-3206
?
mi
from
Boston, MA
Click here to add this to my saved trials