A Unified Treatment for Anxiety Disorders

Study Overview
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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: 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. 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. 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. 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.

Official Title
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Phase 3 of The Development of A Unified Treatment for Anxiety Disorders

Conditions
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Emotional Disorders, Anxiety Disorders

Intervention / Treatment
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* Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders<br>* Cognitive-behavioral treatment in development for emotional disorders<br>|
| No Intervention: 2<br>Wait-list control: Participants were asked to wait 16 weeks before receiving treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule for DSM-IV | DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured Interview Guide for the Hamilton Anxiety Rating Scale | Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reported scores are the mean total scores. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Structured Interview Guide for the Hamilton Depression Rating Scale | Structured Interview Guide for the Hamilton Depression Rating Scale, items are scored on scale of 0 to 4, higher score meaning a higher severity. Total scores can range from 0 (no symptoms) to 53 (severe). Reported scores are a mean of the total scores. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Positive and Negative Affect Scale | Positive and Negative Affect Schedule-Negative Affectivity; Positive and Negative Affect Schedule-Positive Affectivity; Items are rated on a scale of 1 (very slightly or not at all) to 5 (extremely) relating to how a person feels average feels the indicated emotion. Total scores can range from 20 to 100. Higher scores are more severe. Reported scores are based on mean totals. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Beck Depression Inventory - II | Items are measured on a scale from 0 (little to no symptoms) to 3 (severe). Total scores can range from 0 to 63, higher ratings are more severe. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. The reported scores are mean total scores. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Beck Anxiety Inventory | Items are scored on a 0 to 3 scale. Total scores range from 0 to 63. 0-9 is minimal, 10-16 is mild, 17-29 is moderate, and 30-63 is severe. Reported scores are a mean of total scores. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Work and Social Adjustment Scale | Items are scored on a 0 to 8 scale. The total score range is 0 to 40. Higher scores are more severe. Reported scores are means of total scores. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Panic Disorder Severity Scale - Self Report Version | Items are rated on a scale of 0 to 4. Scores can range from 0 to 28. Higher scores indicate higher severity of Panic Disorder symptoms | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Penn State Worry Questionnaire | The PSWQ is a 16-item questionnaire. Items are rated from 1 to 5, and a total score can range from 16 to 80. Higher scores indicate higher severity of worry symptoms. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Social Interaction Anxiety Scale | The SIAS is a twenty-item measure. Experiences are rated on a 5-point scale from 0 to 4. Experiences are rated on a global period of what is typical. A total score of 60 is possible with cutoffs of 34+ indicative of social phobia and 43+ indicative of social anxiety. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Quality of Life Inventory | The QOLI is a 32 item self-report, asking about the importance of 16 domains of life and a participant's satisfaction in each domain. Scores can range from -48 to 115. Higher scores indicate higher quality of life. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Yale-Brown Obsessive Compulsive Scale | The Y-BOCS is a 12-item scale used to see symptom severity of obsessions and compulsions. Items are scored from 0 to 4. The total score can range from 0 to 48. A higher score indicates higher symptom severity. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Emotion Regulation Questionnaire - 2 | The ERQ-2 is a 16 item self-report. Items are scored from 1 to 7, and focus on emotional experience and emotional expression. Scores can range from 16 to 112, and higher scores indicate stronger cognitive reappraisal and expressive suppression abilities. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| BIS/BAS Scales (Carver & White, 1994) | The Behavioral Inhibition System/Behavioral Approach System Scales is a 20-item self-report where all items can be rated from 0 to 3. The total score can range from 0 to 60. Higher scores indicate higher levels of behavioral inhibition skills. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Affective Control Scale | The ACS is a 42 item scale where each item is rated from 1 to 7. Scores can range from 42 to 294. Higher scores indicate higher skill levels for controlling emotions | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Anxiety Sensitivity Index | The ASI is a 16 item self report where items can be scored from 0 to 4. Scores can range from 0 to 64. Higher scores indicate a higher sensitivity to anxiety and it's symptoms. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| The Thought-Action Fusion Scale (Shafran et al., 1996) | The TAF is a 19 item self report where each item can be scored from 0 to 4. Scores can range from 0 to 76. Higher scores indicate a higher frequency of maladaptive cognitive intrusions. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| Intolerance of Uncertainty Scale (IUS) | The IUS is a 27-item self report where each item can be scored from 0 to 4. Scores range from 0 to 108. It rates response to uncertainty, ambiguous situations, and the future. Higher scores indicate higher anxiety and depressive symptoms. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 
| The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995) | The TMMS is a 48 item self report where each item can be scored from 1 to 5. The three subscales are Attention, Clarity, and Repair. Scores for each of the three subscales can each range from 16 to 80. Higher scores indicate higher emotion regulation skills. | Measured at pre-treatment (baseline) and post-treatment (month 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Emotional Disorders, Unified, Depression