Psychotherapy of Generalized Anxiety Disorder

Anxiety Disorders Clinical Trial

Official title:

Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118001
• Other study ID #: HO 1900/3-1, HO 1900/3-2
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: March 31, 2015
• Start date: October 2001
• Est. completion date: July 2006

Study information

• Verified date: June 2005
• Source: German Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Worry exposure

• Applied relaxation

Locations

Country	Name	City	State
Germany	Technische Universität Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At post-treatment: anxiety (Hamilton Anxiety Rating Scale, HARS), depression (Hamilton Depression Scale, HAM-D), trait-anxiety (State-Trait-Anxiety Inventory, STAI-T)
Primary	At 6-month follow-up: M-CIDI (Composite International Diagnostic Interview, generalized anxiety disorder section)
Secondary	At post-treatment, 6 and 12 month follow-ups:
Secondary	worry (Penn State Worry Questionnaire, PSWQ)
Secondary	general symptoms (Brief Symptom Inventory, BSI)
Secondary	depression (Beck Depression Inventory, BDI)
Secondary	interpersonal problems (Inventory of Interpersonal Problems - IIP)
Secondary	meta-cognitions (Meta Cognitions Questionnaire)
Secondary	thought suppression (White Bear Suppression Inventory) tolerance for uncertainty (Ungewissheitstoleranzskala, UGTS)
Secondary	positive and negative affect (Positive and Negative Affect Schedule, PANAS)
Secondary	At post-treatment: behavior assessment tests