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Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

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ClinicalTrials.gov Identifier: NCT02944994
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Anxiety Traumatic Stress Disorders Depression Other: Unified protocol Other: Routine Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care
Study Start Date : December 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR) [ Time Frame: One time assessment, occurring on 1 day, approximately 4 months after treatment initiation ]
    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

  2. Change in clinician administered Anxiety Disorders Interview Scheduled will be used to generate clinical diagnoses for mental health disorders [ Time Frame: 7 months ]
    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

  3. 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 [ Time Frame: 7 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944994


Contacts
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Contact: Caroline Canale, MPH 857-364-3206 caroline.canale@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Stephanie Vento    857-364-3206      
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Cassidy Gutner, PhD Boston University

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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02944994     History of Changes
Other Study ID Numbers: H-33257
K23MH103396 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders