NCT00586001

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

December 11, 2018

Completed
Last Updated

December 11, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

December 21, 2007

Results QC Date

August 3, 2018

Last Update Submit

November 26, 2018

Conditions

Keywords

AnxietyEmotional DisordersUnifiedDepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Structured Interview Guide for the Hamilton Anxiety Rating Scale

    Measured at pre-treatment (baseline) and post-treatment (month 3)

  • Structured Interview Guide for the Hamilton Depression Rating Scale

    Measured at pre-treatment (baseline) and post-treatment (month 3)

  • Positive and Negative Affect Scale

    Measured at pre-treatment (baseline) and post-treatment (month 3)

  • Beck Depression Inventory - II

    Measured at pre-treatment (baseline) and post-treatment (month 3)

  • Beck Anxiety Inventory

    Measured at pre-treatment (baseline) and post-treatment (month 3)

  • +13 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.

Interventions

Cognitive-behavioral treatment in development for emotional disorders

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Diagnosis of a DSM-IV Anxiety Disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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. doi: 10.1037//0021-843x.107.2.179.

    PMID: 9604548BACKGROUND
  • 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. doi: 10.1037//0021-843x.110.4.585.

    PMID: 11727948BACKGROUND
  • Barlow DH. Unraveling the mysteries of anxiety and its disorders from the perspective of emotion theory. Am Psychol. 2000 Nov;55(11):1247-63. doi: 10.1037//0003-066x.55.11.1247.

    PMID: 11280938BACKGROUND
  • Barlow, D.H., Allen, L., & Choate, M.L. (2006). The Unified Protocol for Treatment of the Emotional Disorders. Unpublished manuscript, Boston University.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Todd Farchione
Organization
Boston University Charles River Campus

Study Officials

  • David H Barlow, Ph.D

    Boston University Center for Anxiety and Related Disorders

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology and Psychiatry, Emeritus

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

September 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2010

Last Updated

December 11, 2018

Results First Posted

December 11, 2018

Record last verified: 2018-11