Acceptance-Based Treatment for Generalized Anxiety Disorder | NCT00073632

Studies
Acceptance-Based Treatment for Generalized Anxiety Disorder

NCT00073632

Sponsor

University of Massachusetts, Boston

Status

Completed

Last Update Posted

Nov 6, 2013Estimated

Enrollment

50Actual

Phase

Phase 1

Conditions

Anxiety Disorders
Generalized Anxiety Disorder

Interventions

Acceptance Based Behavioral Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21MH063208	U.S. NIH Grant/Contract		View source
DSIR AT-AS

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Jul 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Dec 2, 2003

First Submission Date that Met QC Criteria

Dec 2, 2003

First Posted Date

Dec 3, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2013

Last Update Posted Date

Nov 6, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Acceptance Based Behavioral Therapy	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Bipolar disorder, psychotic disorder, or substance dependence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lizabeth Roemer, PhD	University of Massachusetts, Boston	Principal Investigator
Susan M Orsillo, PhD	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Anxiety and Related Disorders		Boston	Massachusetts		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17292696	Background	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.

ID	Term
D001008	Anxiety Disorders
D000098647	Generalized Anxiety Disorder