A Unified Treatment for Anxiety Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00586001
First received: December 21, 2007
Last updated: November 29, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Structured Interview Guide for the Hamilton Anxiety Rating Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Structured Interview Guide for the Hamilton Depression Rating Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: Yes ]
  • Beck Anxiety Inventory [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Work and Social Adjustment Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Obsessive Compulsive Inventory - Revised [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale - Self Report Version [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Social Interaction Anxiety Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire - 2 [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • BIS/BAS Scales (Carver & White, 1994) [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Affective Control Scale [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety Sensitivity Index [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • The Thought-Action Fusion Scale (Shafran et al., 1996) [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • Intolerance of Uncertainty Scale (IUS) [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]
  • The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995) [ Time Frame: Measured at months 3 and 9 post-treatment ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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: 5 R34 MH 070693-02, 5 R34 MH 070693-02
Study First Received: December 21, 2007
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Anxiety
Emotional Disorders
Unified
Depression

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

ClinicalTrials.gov processed this record on October 29, 2014