Psychotherapy of Generalized Anxiety Disorder

NCT ID: NCT00118001

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2006-07-31

Brief Summary

The purpose of this study is to compare the effects of worry exposure with the effects of applied relaxation in patients with generalized anxiety disorder.

Detailed Description

Controlled treatment studies show that there is a lower efficacy of cognitive-behavioral treatment of generalized anxiety disorder (GAD) than in other anxiety disorders. The best effect sizes are found for applied relaxation (Öst), but there are only three treatment studies. Another, yet previously not tested in its pure form, approach is "worry-exposure", which aims at confronting the emotionally intensive imaginative contents of worries in GAD.

Fifty-two randomized patients with GAD as a primary diagnosis will be treated with one of the two treatments and will be compared with waiting-list patients. This treatment protocol contains 15 sessions (+/-2) and a 6 month and 12 month follow-up.

The comparisons in this study include: worry exposure versus applied relaxation versus a waiting control group.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Worry exposure

Intervention Type: BEHAVIORAL

Applied relaxation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary Diagnosis of generalized anxiety disorder (according to impairment)
• 18-70 years of age
• Informed consent

Exclusion Criteria

• Not able to understand and speak the German language
• Acute, unstable and severe somatic disease (DSM-IV, Axis III)
• History of schizophrenia or bipolar disorder
• Other mental disorders requiring treatment
• Substance dependence within the past 12 months preceding treatment
• Personality disorders that interfere with treatment compliance
• Participation in any other psychotherapeutic interventions
• Use of anxiolytics (e.g. tranquilizer, hypnotics, neuroleptics; does not include stabile use of antidepressants)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: lead

Principal Investigators

Jürgen Hoyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Eni S Becker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nijmegen

Locations

Technische Universität Dresden

Dresden, , Germany

Countries

Germany

Other Identifiers

HO 1900/3-1, HO 1900/3-2

Identifier Type: -

Identifier Source: org_study_id