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.

Condition	Intervention	Phase
Anxiety Disorders	Behavior: Worry exposure  Behavior: Applied relaxation	Phase III

Further Study Details: 

Primary Outcomes: 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)
Secondary Outcomes: 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
Expected Total Enrollment:  70

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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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)

Germany
      Technische Universität Dresden, Dresden,  01187,  Germany

Study chairs or principal investigators

Jürgen Hoyer, PhD,  Principal Investigator,  Technische Universität Dresden   
Eni S Becker, PhD,  Principal Investigator,  University of Nijmegen   

Study ID Numbers:  HO 1900/3-1, HO 1900/3-2
Last Updated:  July 25, 2005
Record first received:  July 8, 2005
ClinicalTrials.gov Identifier:  NCT00118001
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-08-02