Psychotherapy of Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00118001
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : April 1, 2015
Information provided by:
German Research Foundation

June 30, 2005
July 11, 2005
April 1, 2015
October 2001
Not Provided
  • At post-treatment: anxiety (Hamilton Anxiety Rating Scale, HARS), depression (Hamilton Depression Scale, HAM-D), trait-anxiety (State-Trait-Anxiety Inventory, STAI-T)
  • At 6-month follow-up: M-CIDI (Composite International Diagnostic Interview, generalized anxiety disorder section)
Same as current
Complete list of historical versions of study NCT00118001 on Archive Site
  • At post-treatment, 6 and 12 month follow-ups:
  • worry (Penn State Worry Questionnaire, PSWQ)
  • general symptoms (Brief Symptom Inventory, BSI)
  • depression (Beck Depression Inventory, BDI)
  • interpersonal problems (Inventory of Interpersonal Problems - IIP)
  • meta-cognitions (Meta Cognitions Questionnaire)
  • thought suppression (White Bear Suppression Inventory) tolerance for uncertainty (Ungewissheitstoleranzskala, UGTS)
  • positive and negative affect (Positive and Negative Affect Schedule, PANAS)
  • At post-treatment: behavior assessment tests
Same as current
Not Provided
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Psychotherapy of Generalized Anxiety Disorder
Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anxiety Disorders
  • Behavioral: Worry exposure
  • Behavioral: Applied relaxation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2006
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
HO 1900/3-1, HO 1900/3-2
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German Research Foundation
Not Provided
Principal Investigator: Jürgen Hoyer, PhD Technische Universität Dresden
Principal Investigator: Eni S Becker, PhD University of Nijmegen
German Research Foundation
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP