A Unified Treatment for Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586001
• Other study ID #: 5R34MH070693-02
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: November 2010

Study information

• Verified date: November 2018
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Emotional Disorders
• Mood Disorders

Intervention

Behavioral:
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Cognitive-behavioral treatment in development for emotional disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

References & Publications (4)

Barlow DH. Unraveling the mysteries of anxiety and its disorders from the perspective of emotion theory. Am Psychol. 2000 Nov;55(11):1247-63. — View Citation

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 Unpublished manuscript, Boston University.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Center for Anxiety and Related Disorders at Boston University webpage