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A Unified Treatment for Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT00586001
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : December 1, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Emotional Disorders Anxiety Disorders Behavioral: Unified treatment Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 of The Development of A Unified Treatment for Anxiety Disorders
Study Start Date : September 2005
Primary Completion Date : November 2008
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Unified treatment
Behavioral: Unified treatment
Cognitive-behavioral treatment in development for emotional disorders
No Intervention: 2
Wait-list control


Outcome Measures

Primary Outcome Measures :
  1. Anxiety Disorders Interview Schedule for DSM-IV [ Time Frame: Measured at months 3 and 9 post-treatment ]

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586001


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

Additional Information:
Publications:
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00586001     History of Changes
Other Study ID Numbers: 5R34MH070693-02 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: March 2011

Keywords provided by Boston University:
Anxiety
Emotional Disorders
Unified
Depression

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders