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Clinical Trials/NCT00961493
NCT00961493CompletedNot Applicable

Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder

University of Massachusetts, Boston1 site in 1 country81 target enrollmentStarted: March 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
81
Locations
1
Primary Endpoint
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •principal diagnosis of GAD
  • •at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
  • •willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
  • •fluent in English
  • •18 years or older

Exclusion Criteria

  • •bipolar disorder
  • •psychotic disorders
  • •substance dependence
  • •active suicidal intent
  • •if anxious symptomatology is due to a medical/physical condition

Arms & Interventions

1

Experimental

Intervention: Acceptance based behavioral therapy (Behavioral)

2

Active Comparator

Intervention: Applied relaxation (Behavioral)

Outcomes

Primary Outcomes

Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD

Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Hamilton Anxiety Rating Scale

Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Penn State Worry Questionnaire

Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Secondary Outcomes

  • Beck Depression Inventory - II(pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up)
  • Quality of Life Inventory(pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lizabeth Roemer

Professor of Psychology

University of Massachusetts, Boston

Study Sites (1)

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