Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Traumatic Stress Disorders
• Intervention / Treatment: Other: Unified protocol; Other: Routine Care

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Cassidy Gutner, PhD, Boston University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 12, 2019
• Study Completion (Actual): February 12, 2019

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic
• Other Study ID Numbers: H-33257; K23MH103396 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No