Psychotherapy of Generalized Anxiety Disorder
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ClinicalTrials.gov Identifier: NCT00118001 |
Recruitment Status
:
Completed
First Posted
: July 11, 2005
Last Update Posted
: April 1, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety Disorders | Behavioral: Worry exposure Behavioral: Applied relaxation | Phase 3 |
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) |
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 |
Study Completion Date : | July 2006 |

- 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)
- 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

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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)

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
Germany | |
Technische Universität Dresden | |
Dresden, Germany, 01187 |
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:
Psychotherapy Generalized Anxiety Disorder randomized-controlled trial worry exposure applied relaxation |
Additional relevant MeSH terms:
Disease Anxiety Disorders Pathologic Processes Mental Disorders |