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Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders

NCT ID: NCT01243606

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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The purpose of this proposal is to evaluate efficacy of the recently developed Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). This protocol takes advantage of recent advances in our understanding of the nature of anxiety disorders, as well as emerging knowledge of the process of regulation and change in anxious behavior, in order to distill and refine basic principles of successful psychological treatments for anxiety disorders. It is expected that this approach will simplify training and dissemination, provide better coverage for comorbid conditions, cover "not otherwise specified" (NOS) and sub-definitional threshold presentations, possibly improve efficacy particularly in the long term, and perhaps also shed further light on the nature of anxiety disorders.

A heterogeneous sample of 250 patients meeting diagnostic criteria for at least one of four anxiety disorders: Social Phobia (SAD), Panic Disorder with or without Agoraphobia (PD/A), Generalized Anxiety Disorder (GAD), or Obsessive Compulsive Disorder (OCD) will be randomized to one of three treatment cells: (1) the Unified Protocol (UP); (2) a single diagnosis psychological treatment protocol (SDP); or (3) Wait List (WL). A minimum of 50 patients from each of the 4 principal diagnostic categories will be included in the randomization to ensure adequate representation of each anxiety disorder. The study will consist of two phases: (1) a 12 or 16 week acute treatment phase (or 16 week WL) and (2) a 12-month follow-up phase, during which active treatments will be discontinued and patients will be followed to assess the long-term effects of treatment (outcome measures are discussed below). Patients randomized to the WL condition will not enter the post-treatment period. Rather, they will be immediately assigned to their choice of either UP or SDP treatment at the end of the sixteen week waiting period.

All assessment and treatment procedures will be conducted at the Center for Anxiety and Related Disorders (CARD) at Boston University, which is one of the largest research clinics devoted to anxiety and related emotional disorders in the world. Total duration for participation in the study will not exceed 18 months total.

The major aims of this proposal are to:

Primary Aims

Aim 1: Evaluate the efficacy of the UP applied to a group of patients with heterogeneous anxiety disorders as compared to a group receiving existing evidence-based single diagnosis treatment protocols (SDPs) benchmarked against a wait list control condition (WL) to determine the treatment responsiveness of the sample on common measures of outcome.

Aim 2: Evaluate the efficacy of both the UP and SDPs relative to a benchmark WL condition.

Aim 3: Determine long-term efficacy of UP relative to SDPs over a 1-year period following treatment discontinuation.

Aim 4: Examine the relative effects of each active treatment approach (UP \& SDPs) on comorbid anxiety and depressive disorder severity.

Secondary Aims

Aim 5: Ascertain the relative effects of each active treatment on higher-order temperamental indices.

Aim 6: Determine if change in higher order temperamental variables mediates long term outcome.

Conditions

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Anxiety Disorders Mood Disorders

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Diagnosis Treatment Protocols

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.

Group Type EXPERIMENTAL

Single Diagnosis Treatment Protocol

Intervention Type 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

Unified Protocol

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

Group Type EXPERIMENTAL

Unified Protocol (UP)

Intervention Type 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).

Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Single Diagnosis Treatment Protocol

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

Intervention Type BEHAVIORAL

Unified Protocol (UP)

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* For inclusion, subjects will be males and females 18 years or older, fluent in the English language who have a principal DSM-IV diagnosis of SAD, PD/A, GAD, or OCD. In addition, to be eligible for participation, individuals must be willing to refrain from initiating additional treatment during the course of therapy unless mutually agreed upon with the therapists and the principal investigator; and willing to be randomly assigned to treatment conditions.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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David H. Barlow

Professor of Psychology and Psychiatry, Emeritus. Founder and Director Emeritus, Center for Anxiety and Related Disorders at Boston University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David H Barlow, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37432031 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31253437 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28768327 (View on PubMed)

Related Links

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http://bostonanxietytreatment.com

Visit our website to learn more about the study.

Other Identifiers

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1R01MH090053-01

Identifier Type: NIH

Identifier Source: org_study_id

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