Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/11/2017 |
| Start Date: | December 2010 |
| End Date: | May 2017 |
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.
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.
The purpose of this proposal is to evaluate efficacy of the recently developed Unified
Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). This protocol takes
advantage of recent advances in our understanding of the nature of anxiety disorders, as well
as emerging knowledge of the process of regulation and change in anxious behavior, in order
to distill and refine basic principles of successful psychological treatments for anxiety
disorders. It is expected that this approach will simplify training and dissemination,
provide better coverage for comorbid conditions, cover "not otherwise specified" (NOS) and
sub-definitional threshold presentations, possibly improve efficacy particularly in the long
term, and perhaps also shed further light on the nature of anxiety disorders.
A heterogeneous sample of 250 patients meeting diagnostic criteria for at least one of four
anxiety disorders: Social Phobia (SAD), Panic Disorder with or without Agoraphobia (PD/A),
Generalized Anxiety Disorder (GAD), or Obsessive Compulsive Disorder (OCD) will be randomized
to one of three treatment cells: (1) the Unified Protocol (UP); (2) a single diagnosis
psychological treatment protocol (SDP); or (3) Wait List (WL). A minimum of 50 patients from
each of the 4 principal diagnostic categories will be included in the randomization to ensure
adequate representation of each anxiety disorder. The study will consist of two phases: (1) a
12 or 16 week acute treatment phase (or 16 week WL) and (2) a 12-month follow-up phase,
during which active treatments will be discontinued and patients will be followed to assess
the long-term effects of treatment (outcome measures are discussed below). Patients
randomized to the WL condition will not enter the post-treatment period. Rather, they will be
immediately assigned to their choice of either UP or SDP treatment at the end of the sixteen
week waiting period.
All assessment and treatment procedures will be conducted at the Center for Anxiety and
Related Disorders (CARD) at Boston University, which is one of the largest research clinics
devoted to anxiety and related emotional disorders in the world. Total duration for
participation in the study will not exceed 18 months total.
The major aims of this proposal are to:
Primary Aims
Aim 1: Evaluate the efficacy of the UP applied to a group of patients with heterogeneous
anxiety disorders as compared to a group receiving existing evidence-based single diagnosis
treatment protocols (SDPs) benchmarked against a wait list control condition (WL) to
determine the treatment responsiveness of the sample on common measures of outcome.
Aim 2: Evaluate the efficacy of both the UP and SDPs relative to a benchmark WL condition.
Aim 3: Determine long-term efficacy of UP relative to SDPs over a 1-year period following
treatment discontinuation.
Aim 4: Examine the relative effects of each active treatment approach (UP & SDPs) on comorbid
anxiety and depressive disorder severity.
Secondary Aims
Aim 5: Ascertain the relative effects of each active treatment on higher-order temperamental
indices.
Aim 6: Determine if change in higher order temperamental variables mediates long term
outcome.
Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). This protocol takes
advantage of recent advances in our understanding of the nature of anxiety disorders, as well
as emerging knowledge of the process of regulation and change in anxious behavior, in order
to distill and refine basic principles of successful psychological treatments for anxiety
disorders. It is expected that this approach will simplify training and dissemination,
provide better coverage for comorbid conditions, cover "not otherwise specified" (NOS) and
sub-definitional threshold presentations, possibly improve efficacy particularly in the long
term, and perhaps also shed further light on the nature of anxiety disorders.
A heterogeneous sample of 250 patients meeting diagnostic criteria for at least one of four
anxiety disorders: Social Phobia (SAD), Panic Disorder with or without Agoraphobia (PD/A),
Generalized Anxiety Disorder (GAD), or Obsessive Compulsive Disorder (OCD) will be randomized
to one of three treatment cells: (1) the Unified Protocol (UP); (2) a single diagnosis
psychological treatment protocol (SDP); or (3) Wait List (WL). A minimum of 50 patients from
each of the 4 principal diagnostic categories will be included in the randomization to ensure
adequate representation of each anxiety disorder. The study will consist of two phases: (1) a
12 or 16 week acute treatment phase (or 16 week WL) and (2) a 12-month follow-up phase,
during which active treatments will be discontinued and patients will be followed to assess
the long-term effects of treatment (outcome measures are discussed below). Patients
randomized to the WL condition will not enter the post-treatment period. Rather, they will be
immediately assigned to their choice of either UP or SDP treatment at the end of the sixteen
week waiting period.
All assessment and treatment procedures will be conducted at the Center for Anxiety and
Related Disorders (CARD) at Boston University, which is one of the largest research clinics
devoted to anxiety and related emotional disorders in the world. Total duration for
participation in the study will not exceed 18 months total.
The major aims of this proposal are to:
Primary Aims
Aim 1: Evaluate the efficacy of the UP applied to a group of patients with heterogeneous
anxiety disorders as compared to a group receiving existing evidence-based single diagnosis
treatment protocols (SDPs) benchmarked against a wait list control condition (WL) to
determine the treatment responsiveness of the sample on common measures of outcome.
Aim 2: Evaluate the efficacy of both the UP and SDPs relative to a benchmark WL condition.
Aim 3: Determine long-term efficacy of UP relative to SDPs over a 1-year period following
treatment discontinuation.
Aim 4: Examine the relative effects of each active treatment approach (UP & SDPs) on comorbid
anxiety and depressive disorder severity.
Secondary Aims
Aim 5: Ascertain the relative effects of each active treatment on higher-order temperamental
indices.
Aim 6: Determine if change in higher order temperamental variables mediates long term
outcome.
Inclusion Criteria:
- For inclusion, subjects will be males and females 18 years or older, fluent in the
English language who have a principal DSM-IV diagnosis of SAD, PD/A, GAD, or OCD. In
addition, to be eligible for participation, individuals must be willing to refrain
from initiating additional treatment during the course of therapy unless mutually
agreed upon with the therapists and the principal investigator; and willing to be
randomly assigned to treatment conditions.
Exclusion Criteria:
- Patients will be excluded if they meet any of the following criteria:
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective
disorder, or organic mental disorder.
- Clear and current suicidal risk.
- Current or recent (past 90 days) history of substance abuse or drug dependence,
with the exception of nicotine, marijuana, and caffeine.
Individuals will also be excluded if they previously received an adequate trial of CBT or
if their emotional symptomatology is due to a medical/physical condition in which case
alternative treatment would be clinically indicated.
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