A Unified Treatment for Anxiety Disorders

Boston University Charles River Campus

Status: Completed

Conditions: Emotional Disorders; Anxiety Disorders

Treatments: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT00586001

5R34MH070693-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

37 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

2

No Intervention group

Description:

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