Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders

NCT01243606 | Completed DMC

• 1 other identifier: 1R01MH090053-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Deepening understanding of the nature of anxiety and related emotional disorders during the last decade has revealed that commonalities in etiology and latent structure among these disorders supersedes differences. At the same time, examination of extant single diagnosis psychological treatment protocols (SDPs) for these disorders underscores mechanistic similarities. These findings suggested the possibility of distilling a set of psychological procedures that would comprise an innovative Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been developed. If efficacious, the UP may represent a more efficient and possibly more effective strategy which would render treatment implications of comorbidity, not otherwise specified (NOS) and subdefinitional threshold anxiety disorder conditions moot. The investigators now propose an evaluation of the efficacy of the UP in a group of patients with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence based SDPs benchmarked against a wait list control condition, using both statistical equivalence and superiority analyses. Additional aims include determining the durability of the UP relative to comparison conditions after treatment discontinuation, and ascertaining the differential impact of treatments on disorder specific symptoms vs. higher-order temperamental variables. Further analyses will indicate if changes in these higher order temperamental variables mediate long-term outcome as preliminary data suggests, and if this mechanism of action differs among treatments.

Conditions

Anxiety Disorders; Mood Disorders

Keywords

Anxiety; Depression; Obsessive Compulsive Disorder; Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Transdiagnostic Treatment; CBT

Outcome Measures

Primary Outcomes (1)

• Anxiety Disorders Interview Schedule (ADIS): change over time

  The ADIS is a semi-structured diagnostic interview designed to establish reliable DSM anxiety, mood, somatoform and substance use disorders. For each current diagnosis, interviewers assigned a 0-8 clinical severity rating (CSR) that indicates their judgment of the degree of distress and impairment associated with the disorder (0=none to 8=very severely disturbing/disabling). The information derived from the interview using the ADIS allows clinicians to determine differential diagnoses and gain a clear understanding of the level and severity of each diagnosis.

  Baseline, every 4 weeks during a 16 week treatment or waitlist period, 6-month follow-up, 12-month follow-up

Secondary Outcomes (8)

• Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I): change over time

  Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up

• Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D): change over time

  Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up

• Yale-Brown Obsessive Compulsive Scale Interview-II (Y-BOCS-II): change over time

  Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up

• Panic Disorder Severity Scale (PDSS): change over time

  Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up

• Liebowitz Social Anxiety Scale (LSAS): change over time

  Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up

Study Arms (3)

Single Diagnosis Treatment Protocols

EXPERIMENTAL

Four disorder-specific cognitive-behavioral treatments will be conducted in accordance with treatment manuals of demonstrated efficacy. SDPs will be matched to the principal anxiety disorder diagnosis.

Behavioral: Single Diagnosis Treatment Protocol

Unified Protocol

EXPERIMENTAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders will be individually administered in accordance with a treatment protocol.

Behavioral: Unified Protocol (UP)

Waitlist Control

NO INTERVENTION

Waitlist participants will not receive treatment during a 16-week waitlist period, but will receive the treatment of their choice immediately following the 16 week waiting period.

Interventions

Single Diagnosis Treatment Protocol BEHAVIORAL

SDPs include: Managing Social Anxiety: A CBT Approach; Mastery of Anxiety and Panic-IV; Mastery of Anxiety and Worry-II; and Obsessive-Compulsive Disorder: A CBT Approach

Single Diagnosis Treatment Protocols

Unified Protocol (UP) BEHAVIORAL

The UP is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. Treatment and session length of the UP will be matched to the SDPs for each principal diagnosis (see description above).

Unified Protocol

Eligibility Criteria

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

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Current DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder.
• Clear and current suicidal risk.
• Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine.
• Individuals will also be excluded if they previously received an adequate trial of CBT or if their emotional symptomatology is due to a medical/physical condition in which case alternative treatment would be clinically indicated.

Sponsors & Collaborators

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

Study Sites (1)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• Cardona ND, Ametaj AA, Cassiello-Robbins C, Tirpak JW, Olesnycky O, Sauer-Zavala S, Farchione TJ, Barlow DH. Outcomes of People of Color in an Efficacy Trial of Cognitive-Behavioral Treatments for Anxiety, Depression, and Related Disorders: Preliminary Evidence. J Nerv Ment Dis. 2023 Sep 1;211(9):711-720. doi: 10.1097/NMD.0000000000001692. Epub 2023 Jul 10.

  PMID: 37432031 DERIVED

• Wilner Tirpak J, Cassiello-Robbins C, Ametaj A, Olesnycky OS, Sauer-Zavala S, Farchione TJ, Barlow DH. Changes in positive affect in cognitive-behavioral treatment of anxiety disorders. Gen Hosp Psychiatry. 2019 Nov-Dec;61:111-115. doi: 10.1016/j.genhosppsych.2019.06.008. Epub 2019 Jun 17.

  PMID: 31253437 DERIVED

• Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.

  PMID: 28768327 DERIVED

Related Links

• Visit our website to learn more about the study.

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Depression; Obsessive-Compulsive Disorder; Panic Disorder; Generalized Anxiety Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Phobic Disorders

Study Officials

• David H Barlow, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Psychiatry, Emeritus. Founder and Director Emeritus, Center for Anxiety and Related Disorders at Boston University

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 18, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

US (1)