The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial

Abstract

Importance: Transdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments.

Objective: To determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders.

Design, setting, and participants: From June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat.

Interventions: The UP or SDPs.

Main outcomes and measures: Blinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs.

Results: Among the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs.

Conclusions and relevance: The UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders.

Trial registration: clinicaltrials.gov Identifier: NCT01243606.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Barlow reported receiving royalties from Oxford University Press (which includes royalties for all 5 treatment manuals included in this study), Guilford Publications Inc, Cengage Learning, and Pearson Publishing; receiving grants from the National Institute of Mental Health, the National Institute of Alcohol and Alcohol Abuse, and Colciencias (Government of Columbia Initiative for Science, Technology, and Health Innovation); serving as a consultant for and receiving honoraria from the Agency for Healthcare Research and Quality, the Foundation for Informed Medical Decision Making, the Department of Defense, the Renfrew Center, the Chinese University of Hong Kong, Universidad Católica de Santa Maria (Arequipa, Peru), New Zealand Psychological Association, Hebrew University of Jerusalem, Mayo Clinic, and various American universities. Dr Farchione reported receiving royalties from Oxford University Press for one of the treatment manuals included in this study. No other disclosures were reported.

Figures

Figure 1.. Recruitment Flow Diagram

SDP indicates single-disorder protocol; UP, Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; and WLC, waitlist control. aCompleted treatment indicates that the patient attended at least 75% of the allotted number of sessions (ie, 9 of 12 for patients with panic disorder with or without agoraphobia and 12 of 16 for patients with other principal diagnoses). bOne patient with principal panic disorder with or without agoraphobia completed 12 sessions but was withdrawn before the posttreatment assessment (ie, completed treatment, but was not eligible for posttreatment assessment). cOne patient was withdrawn from the study after completing the posttreatment assessment, but before the 6-month follow-up, so was no longer eligible for 6-month follow-up; however, this individual is included in the “eligible for posttreatment and 6-month follow-up” classification (n = 78).

Figure 2.. Model-Based Estimates of the Principal Diagnosis ADIS CSR Score Trajectories From Baseline to 6-Month Follow-up

Development of mean clinical severity rating for patients’ principal diagnosis in each condition throughout the study. ADIS CSR indicates clinical severity rating for principal diagnosis obtained from Anxiety Disorder Interview Schedule; SDP, single-disorder protocol; UP, Unified Protocol; and WLC, waitlist control.