NCT00073632

Brief Summary

This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

May 1, 2002

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 6, 2013

Status Verified

September 1, 2008

Enrollment Period

4.2 years

First QC Date

December 2, 2003

Last Update Submit

November 5, 2013

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

  • Clinician Severity Rating from ADIS for GAD

    pre, post, 3 mo. f/u, 9 mo. f/u

  • Penn State Worry Questionnaire

    pre-, post-, 3 mo. f/u, 9 mo. f/u

  • Depression Anxiety and Stress Scales, anxiety and stress subscales

    pre-, post-, 3 mo. f/u, 9 mo. f/u

Interventions

Acceptance Based Behavioral TherapyBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Generalized Anxiety Disorder (GAD)
  • Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study

You may not qualify if:

  • Bipolar disorder, psychotic disorder, or substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Anxiety and Related Disorders

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.

    PMID: 17292696BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Lizabeth Roemer, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

  • Susan M Orsillo, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2003

First Posted

December 3, 2003

Study Start

May 1, 2002

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

November 6, 2013

Record last verified: 2008-09

Locations

US(1)