We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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
Information provided by:
German Research Foundation

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Worry exposure Behavioral: Applied relaxation Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
Study Start Date : October 2001
Estimated Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Primary Outcome Measures :
  1. At post-treatment: anxiety (Hamilton Anxiety Rating Scale, HARS), depression (Hamilton Depression Scale, HAM-D), trait-anxiety (State-Trait-Anxiety Inventory, STAI-T)
  2. At 6-month follow-up: M-CIDI (Composite International Diagnostic Interview, generalized anxiety disorder section)

Secondary Outcome Measures :
  1. At post-treatment, 6 and 12 month follow-ups:
  2. worry (Penn State Worry Questionnaire, PSWQ)
  3. general symptoms (Brief Symptom Inventory, BSI)
  4. depression (Beck Depression Inventory, BDI)
  5. interpersonal problems (Inventory of Interpersonal Problems - IIP)
  6. meta-cognitions (Meta Cognitions Questionnaire)
  7. thought suppression (White Bear Suppression Inventory) tolerance for uncertainty (Ungewissheitstoleranzskala, UGTS)
  8. positive and negative affect (Positive and Negative Affect Schedule, PANAS)
  9. At post-treatment: behavior assessment tests

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118001

Technische Universität Dresden
Dresden, Germany, 01187
Sponsors and Collaborators
German Research Foundation
Principal Investigator: Jürgen Hoyer, PhD Technische Universität Dresden
Principal Investigator: Eni S Becker, PhD University of Nijmegen

ClinicalTrials.gov Identifier: NCT00118001     History of Changes
Other Study ID Numbers: HO 1900/3-1, HO 1900/3-2
First Posted: July 11, 2005    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: June 2005

Keywords provided by German Research Foundation:
Generalized Anxiety Disorder
randomized-controlled trial
worry exposure
applied relaxation

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders