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NCT01243606 · ClinicalTrials.gov registry record · NA
Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders
A NA study of Anxiety Disorders and Mood Disorders, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT01243606: Completed NA study of Anxiety Disorders and Mood Disorders, sponsored by Boston University Charles River Campus.
NCT01243606 is a NA study of Anxiety Disorders and Mood Disorders that has completed, run by Boston University Charles River Campus. The registered enrollment target is 250 participants, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243606, a NA study of Anxiety Disorders and Mood Disorders, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Deepening understanding of the nature of anxiety and related emotional disorders during the last decade has revealed that commonalities in etiology and latent structure among these disorders supersedes differences. At the same time, examination of extant single diagnosis psychological treatment protocols (SDPs) for these disorders underscores mechanistic similarities. These findings suggested the possibility of distilling a set of psychological procedures that would comprise an innovative Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been developed. If efficacious, the UP may represent a more efficient and possibly more effective strategy which would render treatment implications of comorbidity, not otherwise specified (NOS) and subdefinitional threshold anxiety disorder conditions moot. The investigators now propose an evaluation of the efficacy of the UP in a group of patients with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence based SDPs benchmarked against a wait list control condition, using both statistical equivalence and superiority analyses. Additional aims include determining the durability of the UP relative to comparison conditions after treatment discontinuation, and ascertaining the differential impact of treatments on disorder specific symptoms vs. higher-order temperamental variables. Further analyses will indicate if changes in these higher order temperamental variables mediate long-term outcome as preliminary data suggests, and if this mechanism of action differs among treatments.
Primary Outcome
The ADIS is a semi-structured diagnostic interview designed to establish reliable DSM anxiety, mood, somatoform and substance use disorders. For each current diagnosis, interviewers assigned a 0-8 clinical severity rating (CSR) that indicates their judgment of the degree of distress and impairment associated with the disorder (0=none to 8=very severely disturbing/disabling). The information derived from the interview using the ADIS allows clinicians to determine differential diagnoses and gain a
Conditions Studied
Interventions
- BEHAVIORAL Single Diagnosis Treatment Protocol
- BEHAVIORAL Unified Protocol (UP)
Study Locations (1)
Massachusetts
- Center for Anxiety and Related Disorders at Boston University - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-05 |
| Phase | NA |
What the finished NCT01243606 record still lists
NCT01243606 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Single Diagnosis Treatment Protocol is the first listed.
NCT01243606 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01243606 about?
NCT01243606 is a clinical study titled "Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders". Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Deepening understanding of the nature of anxiety and related emotional disorders during the last decad...
What is the current status of trial NCT01243606?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2010-12. Estimated completion is 2017-05.
What conditions does trial NCT01243606 study?
This clinical trial studies the following conditions: Anxiety Disorders, Mood Disorders.
What interventions are being tested in trial NCT01243606?
The interventions under investigation include: Single Diagnosis Treatment Protocol (BEHAVIORAL), Unified Protocol (UP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01243606?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01243606 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01243606's enrollment target sits among peer trials
250 20th of 84 higher than 65 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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