Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

NCT ID: NCT02944994

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-02-12

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.

Conditions

Anxiety; Traumatic Stress Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Unified Protocol

Unified Protocol-psychotherapy

Group Type: EXPERIMENTAL

Unified protocol

Intervention Type: OTHER

This is a transdiagnostic cognitive behavioral therapy

Routine Care

Routine Care psychotherapy comparison

Group Type: EXPERIMENTAL

Routine Care

Intervention Type: OTHER

This arm will reflect typical care received in routine mental health care

Interventions

Unified protocol

This is a transdiagnostic cognitive behavioral therapy

Intervention Type: OTHER

Routine Care

This arm will reflect typical care received in routine mental health care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cassidy Gutner, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

VA Boston Healthcare System

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36258655 (View on PubMed)

Other Identifiers

K23MH103396

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-33257

Identifier Type: -

Identifier Source: org_study_id