Effectiveness of a Unified Transdiagnostic Treatment in Routine Care

NCT02944994 | Completed

• 2 other identifiers: H-33257K23MH103396
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Traumatic Stress Disorders; Depression

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Unified Protocol

EXPERIMENTAL

Unified Protocol-psychotherapy

Other: Unified protocol

Routine Care

EXPERIMENTAL

Routine Care psychotherapy comparison

Other: Routine Care

Interventions

Unified protocol OTHER

This is a transdiagnostic cognitive behavioral therapy

Unified Protocol

Routine Care OTHER

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

Routine Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

• 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.

  PMID: 36258655 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Traumatic; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cassidy Gutner, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: October 26, 2016
• Study Start: December 1, 2014
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)