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A Unified Treatment for Anxiety Disorders

NCT ID: NCT00586001

Last Updated: 2018-12-11

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Emotional Disorders Anxiety Disorders

Keywords

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Anxiety Emotional Disorders Unified Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.

Group Type EXPERIMENTAL

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

Cognitive-behavioral treatment in development for emotional disorders

2

Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Cognitive-behavioral treatment in development for emotional disorders

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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David H. Barlow

Professor of Psychology and Psychiatry, Emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David H Barlow, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Boston University Center for Anxiety and Related Disorders

Countries

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United States

References

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Brown TA, Chorpita BF, Barlow DH. Structural relationships among dimensions of the DSM-IV anxiety and mood disorders and dimensions of negative affect, positive affect, and autonomic arousal. J Abnorm Psychol. 1998 May;107(2):179-92. doi: 10.1037//0021-843x.107.2.179.

Reference Type BACKGROUND
PMID: 9604548 (View on PubMed)

Brown TA, Campbell LA, Lehman CL, Grisham JR, Mancill RB. Current and lifetime comorbidity of the DSM-IV anxiety and mood disorders in a large clinical sample. J Abnorm Psychol. 2001 Nov;110(4):585-99. doi: 10.1037//0021-843x.110.4.585.

Reference Type BACKGROUND
PMID: 11727948 (View on PubMed)

Barlow DH. Unraveling the mysteries of anxiety and its disorders from the perspective of emotion theory. Am Psychol. 2000 Nov;55(11):1247-63. doi: 10.1037//0003-066x.55.11.1247.

Reference Type BACKGROUND
PMID: 11280938 (View on PubMed)

Barlow, D.H., Allen, L., & Choate, M.L. (2006). The Unified Protocol for Treatment of the Emotional Disorders. Unpublished manuscript, Boston University.

Reference Type BACKGROUND

Related Links

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http://www.bu.edu/anxiety

Center for Anxiety and Related Disorders at Boston University webpage

Other Identifiers

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5R34MH070693-02

Identifier Type: NIH

Identifier Source: org_study_id

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