Psychotherapy of Generalized Anxiety Disorder

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00118001 History of Changes
Other Study ID Numbers:	HO 1900/3-1, HO 1900/3-2
First Posted:	July 11, 2005
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