Clinical trial NCT02944994: Effectiveness of a Unified Transdiagnostic Treatment in Routine Care
Official title: Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Traumatic Stress Disorders
Depression
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-10-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR)
timeFrame: One time assessment, occurring on 1 day, approximately 4 months after treatment initiation
measure: Change in clinician administered Anxiety Disorders Interview Scheduled will be used to generate clinical diagnoses for mental health disorders
timeFrame: 7 months
measure: 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
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: Boston University
name: Cassidy Gutner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutner CA, Song J, Canale CA, Suvak MK, Litwack SD, Niles BL, Stirman SW. A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. Depress Anxiety. 2022 Dec;39(12):813-823. doi: 10.1002/da.23288. Epub 2022 Oct 18.