Clinical trial NCT00586001: A Unified Treatment for Anxiety Disorders
Official title: Phase 3 of The Development of A Unified Treatment for Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Disorders
Anxiety Disorders
Keywords: Anxiety
Emotional Disorders
Unified
Depression
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Secondary outcomes:
measure: Structured Interview Guide for the Hamilton Anxiety Rating Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Structured Interview Guide for the Hamilton Depression Rating Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Positive and Negative Affect Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Beck Depression Inventory - II
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Beck Anxiety Inventory
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Work and Social Adjustment Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Panic Disorder Severity Scale - Self Report Version
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Penn State Worry Questionnaire
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Social Interaction Anxiety Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Quality of Life Inventory
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Emotion Regulation Questionnaire - 2
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: BIS/BAS Scales (Carver & White, 1994)
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Affective Control Scale
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Anxiety Sensitivity Index
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: The Thought-Action Fusion Scale (Shafran et al., 1996)
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: Intolerance of Uncertainty Scale (IUS)
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
measure: The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
timeFrame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Other outcomes:
Locations:
Study officials:
affiliation: Boston University Center for Anxiety and Related Disorders
name: David H Barlow, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Barlow, D.H., Allen, L., & Choate, M.L. (2006). The Unified Protocol for Treatment of the Emotional Disorders. Unpublished manuscript, Boston University.