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
  Purpose

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
Behavioral: Worry exposure
Behavioral: Applied relaxation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by German Research Foundation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 70
Study Start Date: October 2001
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118001

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

No publications provided

ClinicalTrials.gov Identifier: NCT00118001     History of Changes
Other Study ID Numbers: HO 1900/3-1, HO 1900/3-2
Study First Received: June 30, 2005
Last Updated: July 20, 2005
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014