Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Boston University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01243606
First received: November 12, 2010
Last updated: March 17, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Anxiety Disorders
Mood Disorders
Behavioral: Single Diagnosis Treatment Protocol
Behavioral: Unified Protocol (UP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The ADIS-IV is a semi-structured diagnostic interview designed to establish reliable DSM-IV anxiety, mood, somatoform and substance 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.

  • Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    These widely used clinician-rated instruments assess global severity and improvement from pre-treatment baseline on 7-point scales. The CGI-S and CGI-I will be used to define clinical response. At the comprehensive assessments, sections of the ADIS-IV (see above) will be used to assist in the determination of the CGI scores.

  • Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The SIGH-A and SIGH-D were developed to create a structured format for administering the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) and the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960). Both include specific instructions on administration and anchor points for assigning severity ratings.

  • Mini or Superlite-ADIS-IV [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Superlite-ADIS-IV [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Superlite-ADIS-IV [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Superlite-ADIS-IV [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Superlite-ADIS-IV [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
    These widely used clinician-rated instruments assess global severity and improvement from pre-treatment baseline on 7-point scales. The CGI-S and CGI-I will be used to define clinical response. At the comprehensive assessments, sections of the ADIS-IV (see above) will be used to assist in the determination of the CGI scores.

  • Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
    The SIGH-A and SIGH-D were developed to create a structured format for administering the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) and the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960). Both include specific instructions on administration and anchor points for assigning severity ratings.

  • Superlite-ADIS-IV [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    These widely used clinician-rated instruments assess global severity and improvement from pre-treatment baseline on 7-point scales. The CGI-S and CGI-I will be used to define clinical response. At the comprehensive assessments, sections of the ADIS-IV (see above) will be used to assist in the determination of the CGI scores.

  • Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D) [ Time Frame: 6-month Follow-up ] [ Designated as safety issue: No ]
    The SIGH-A and SIGH-D were developed to create a structured format for administering the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) and the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960). Both include specific instructions on administration and anchor points for assigning severity ratings.

  • Superlite-ADIS-IV [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.

  • Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
    These widely used clinician-rated instruments assess global severity and improvement from pre-treatment baseline on 7-point scales. The CGI-S and CGI-I will be used to define clinical response. At the comprehensive assessments, sections of the ADIS-IV (see above) will be used to assist in the determination of the CGI scores.

  • Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
    The SIGH-A and SIGH-D were developed to create a structured format for administering the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) and the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960). Both include specific instructions on administration and anchor points for assigning severity ratings.

  • Superlite-ADIS-IV [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
    Comprised of specific sections taken from an abbreviated version of the full ADIS, focusing only on current symptomatology and corresponding to those disorders identified at the initial intake.


Secondary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale Interview (Y-BOCS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder Severity Scale (GADSS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Post-Traumatic Stress Disorder (PTSD) Symptom Scale-Interview Version (PSS-I) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Credibility/Expectancy Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Rand-modified, Medical Outcomes Study 36-item Short-Form Health Survey (Rand-MOS-SF-36) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • University of Rhode Island Change Assessment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Anxiety Control Questionnaire Revised (ACQ-R) [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire-Revised-Short Form (EPQR-S) [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Session 1 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 2 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 3 ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Anxiety Control Questionnaire Revised (ACQ-R) [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire-Revised - Short Form (EPQR-S) [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Session 4 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 5 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 6 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 7 ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Anxiety Control Questionnaire Revised (ACQ-R) [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire-Revised - Short Form (EPQR-S) [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Session 8 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 9 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 10 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 11 ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Anxiety Control Questionnaire Revised (ACQ-R) [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire-Revised - Short Form (EPQR-S) [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Session 12 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 13 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 14 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 15 ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Homework Compliance Scale [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Anxiety Control Questionnaire Revised (ACQ-R) [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Behavioral Inhibition/Behavioral Activation Scale (BIS/BAS) [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Eysenck Personality Questionnaire-Revised - Short Form (EPQR-S) [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Session 16 ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Interview (Y-BOCS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder Severity Scale (GADSS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Post-Traumatic Stress Disorder (PTSD) Symptom Scale-Interview Version (PSS-I) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Rand-modified, Medical Outcomes Study 36-item Short-Form Health Survey (Rand-MOS-SF-36) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline) ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Interview (Y-BOCS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder Severity Scale (GADSS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Post-Traumatic Stress Disorder (PTSD) Symptom Scale-Interview Version (PSS-I) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Rand-modified, Medical Outcomes Study 36-item Short-Form Health Survey (Rand-MOS-SF-36) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Interview (Y-BOCS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale (PDSS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder Severity Scale (GADSS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Post-Traumatic Stress Disorder (PTSD) Symptom Scale-Interview Version (PSS-I) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Rand-modified, Medical Outcomes Study 36-item Short-Form Health Survey (Rand-MOS-SF-36) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  • Overall Anxiety Sensitivity and Impairment Scale (OASIS) [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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
Experimental: Unified Protocol
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders will be individually administered in accordance with a treatment protocol.
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).
No Intervention: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243606

Contacts
Contact: David H Barlow, Ph.D. 617-353-9610 dhbarlow@bu.edu
Contact: Todd J. Farchione, Ph.D. 617-353-9610 tfarchio@bu.edu

Locations
United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Meghan Fortune, B.S.    617-353-9610    fortunem@bu.edu   
Principal Investigator: David H. Barlow, Ph.D         
Sub-Investigator: Timothy A Brown, Psy.D.         
Sub-Investigator: Todd J Farchione, Ph.D.         
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: David H Barlow, Ph.D. Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01243606     History of Changes
Other Study ID Numbers: 1R01MH090053-01
Study First Received: November 12, 2010
Last Updated: March 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Anxiety
Depression
Obsessive Compulsive Disorder
Panic Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Transdiagnostic Treatment
CBT

Additional relevant MeSH terms:
Anxiety Disorders
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014