A Unified Treatment for Anxiety Disorders

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00586001

Enrollment

Registered

2008-01-04

Start date

2005-09-30

Completion date

2010-11-30

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Emotional Disorders

Keywords

Anxiety, Emotional Disorders, Unified, Depression

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.

Interventions

BEHAVIORALUnified Protocol for Transdiagnostic Treatment of Emotional Disorders

Cognitive-behavioral treatment in development for emotional disorders

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Anxiety Disorders Interview Schedule for DSM-IV	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.

Secondary

Measure	Time frame	Description
Structured Interview Guide for the Hamilton Depression Rating Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Positive and Negative Affect Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Beck Depression Inventory - II	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Beck Anxiety Inventory	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Work and Social Adjustment Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Panic Disorder Severity Scale - Self Report Version	Measured at pre-treatment (baseline) and post-treatment (month 3)	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
Penn State Worry Questionnaire	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Social Interaction Anxiety Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Structured Interview Guide for the Hamilton Anxiety Rating Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Yale-Brown Obsessive Compulsive Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Emotion Regulation Questionnaire - 2	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
BIS/BAS Scales (Carver & White, 1994)	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Affective Control Scale	Measured at pre-treatment (baseline) and post-treatment (month 3)	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
Anxiety Sensitivity Index	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
The Thought-Action Fusion Scale (Shafran et al., 1996)	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Intolerance of Uncertainty Scale (IUS)	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.
Quality of Life Inventory	Measured at pre-treatment (baseline) and post-treatment (month 3)	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.

Participant flow

Participants by arm

Arm	Count
Unified Treatment Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.	26
Wait-list Control Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.	11
Total	37

Baseline characteristics

Characteristic	Wait-list Control	Unified Treatment	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	11 Participants	26 Participants	37 Participants
Age, Continuous	30.64 years	29.38 years	30.01 years
Region of Enrollment United States	11 participants	26 participants	37 participants
Sex: Female, Male Female	6 Participants	16 Participants	22 Participants
Sex: Female, Male Male	5 Participants	10 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 26	0 / 11
serious Total, serious adverse events	0 / 26	0 / 11

Outcome results

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.