Psychotherapy of Generalized Anxiety Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Worry exposure
* Behavioral: Applied relaxation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Worry exposure|nan|
|Behavioral: Applied relaxation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation