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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.
 
ClinicalTrials.gov Identifier: NCT00118001
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : April 1, 2015
Sponsor:
Information provided by:
German Research Foundation

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 11, 2005
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2005)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychotherapy of Generalized Anxiety Disorder
Official Title  ICMJE Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Behavioral: Worry exposure
  • Behavioral: Applied relaxation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 8, 2005)
70
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118001
Other Study ID Numbers  ICMJE HO 1900/3-1, HO 1900/3-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE German Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jürgen Hoyer, PhD Technische Universität Dresden
Principal Investigator: Eni S Becker, PhD University of Nijmegen
PRS Account German Research Foundation
Verification Date June 2005

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