Psychotherapy of Generalized Anxiety Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by German Research Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
German Research Foundation
ClinicalTrials.gov Identifier:
NCT00118001
First received: June 30, 2005
Last updated: July 20, 2005
Last verified: June 2005

June 30, 2005
July 20, 2005
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 ClinicalTrials.gov 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
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anxiety Disorders
  • Behavioral: Worry exposure
  • Behavioral: Applied relaxation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00118001
HO 1900/3-1, HO 1900/3-2
Not Provided
Not Provided
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