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A Unified Treatment for Anxiety Disorders

This study has been completed.
Information provided by (Responsible Party):
Boston University Identifier:
First received: December 21, 2007
Last updated: November 29, 2011
Last verified: March 2011
The purpose of this study is to develop a new psychological therapy for a variety of different types of emotional disorders. The study will compare symptoms and functioning of clients who receive the treatment with those who do not, and will include a number of assessments before, during, and after treatment. We predict that patients receiving active treatment will show improved functioning relative to wait-list control.

Condition Intervention Phase
Emotional Disorders
Anxiety Disorders
Behavioral: Unified treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 of The Development of A Unified 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 [ Time Frame: Measured at months 3 and 9 post-treatment ]

Secondary Outcome Measures:
  • Structured Interview Guide for the Hamilton Anxiety Rating Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Structured Interview Guide for the Hamilton Depression Rating Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Positive and Negative Affect Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Beck Depression Inventory - II [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Beck Anxiety Inventory [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Work and Social Adjustment Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Obsessive Compulsive Inventory - Revised [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Panic Disorder Severity Scale - Self Report Version [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Penn State Worry Questionnaire [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Social Interaction Anxiety Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Quality of Life Inventory [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Emotion Regulation Questionnaire - 2 [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • BIS/BAS Scales (Carver & White, 1994) [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Affective Control Scale [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Anxiety Sensitivity Index [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • The Thought-Action Fusion Scale (Shafran et al., 1996) [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • Intolerance of Uncertainty Scale (IUS) [ Time Frame: Measured at months 3 and 9 post-treatment ]
  • The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995) [ Time Frame: Measured at months 3 and 9 post-treatment ]

Enrollment: 40
Study Start Date: September 2005
Study Completion Date: November 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Unified treatment
Behavioral: Unified treatment
Cognitive-behavioral treatment in development for emotional disorders
No Intervention: 2
Wait-list control

Detailed Description:

Emotional disorders, specifically anxiety disorders and depression, are common, chronic, costly, and debilitating to quality of life (Barlow, 2002). Best estimates from various epidemiological studies place the one year prevalence of any anxiety disorder for individuals over 18 at 11.8%, and the one year prevalence of any mood disorder 5.1% (Narrow, Rae, Robins, & Regier, 2002). Lifetime rates are higher. We understand the nature and causes of anxiety and unipolar mood disorders (major depressive disorder and dysthymia) somewhat better than 10 years ago, with evidence pointing to generalized biological and psychological vulnerabilities interacting with specific learning and, sometimes, stressful triggering life events as etiological factors (Barlow, 2002; Brown, Chorpita, & Barlow, 1998). Pharmacological and psychological treatments have been proven effective, at least in the short term, but most studies have ignored the effects of treatment on broad-based patterns of comorbidity that accompany these disorders. Most comorbid disorders are usually additional emotional disorders (Brown, Campbell, Lehman, Grisham, & Mancill, 2001). More importantly, treatment outcomes have been less than satisfactory or ineffective for up to 50% of patients, even for the principal disorder (Nathan & Gorman, 2002). A common pharmacological treatment exists for many emotional disorders, which is selective serotonin re-uptake inhibitors (SSRIs) and closely related compounds. Effective psychological treatments, on the other hand, have been developed to be very specific to each DSM-IV diagnostic category. The purpose of this proposal is to create a unified psychological approach to the emotional disorders. To do, this we will take advantage of recent advances in our understanding of the nature of emotional disorders, as well as emerging knowledge of the process of regulation and change in emotional behavior, in order to distill and refine basic principles of successful psychological treatments. It is expected that this approach will simplify training and dissemination, possibly improve efficacy, and perhaps also shed further light on the nature of emotional disorders. Thus, the specific aims of this proposal are to:

  1. Develop and refine a unified psychological treatment for anxiety and non-bipolar mood disorders derived from distilling the major ingredients of current effective approaches in light of advancing knowledge of emotion regulation and modification.
  2. Revise and develop methods of evaluating adherence and outcome utilizing this new treatment protocol, focusing not only on symptom reduction but also quality of life and adaptive functioning.
  3. Treat a small number of patients with heterogeneous DSM-IV mood and anxiety diagnoses with this new protocol with the purpose of making appropriate modifications for a subsequent pilot study.
  4. Conduct a pilot study testing this unified treatment in comparison to a wait-list control condition in order to determine credibility and efficacy in terms of both symptomatic functioning and quality of life, and relating these outcomes to those from more disorder specific treatments.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary Diagnosis of a DSM-IV Anxiety Disorder

Exclusion Criteria:

  • Previous treatment with cognitive-behavioral therapy
  • Receiving concurrent psychological treatments during study
  • If on psychotropic medicine, requirement for stable dose for at least three months before treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00586001

Sponsors and Collaborators
Boston University
Principal Investigator: David H Barlow, Ph.D Boston University Center for Anxiety and Related Disorders
  More Information

Additional Information:
Responsible Party: Boston University Identifier: NCT00586001     History of Changes
Other Study ID Numbers: 5R34MH070693-02 ( US NIH Grant/Contract Award Number )
Study First Received: December 21, 2007
Last Updated: November 29, 2011

Keywords provided by Boston University:
Emotional Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders processed this record on May 22, 2017