Psychotherapy of Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Anxiety Disorders

• Registration Number: NCT00118001
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2001-10
• Status Verified: 2005-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-11
• Study Completion: 2006-07
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Technische Universität Dresden; 🇩🇪 Dresden, Germany