Anxiety Disorders
Conditions
Keywords
Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation
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.
Interventions
BEHAVIORALWorry exposure
BEHAVIORALApplied relaxation
Sponsors
German Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| general symptoms (Brief Symptom Inventory, BSI) | — |
| depression (Beck Depression Inventory, BDI) | — |
| interpersonal problems (Inventory of Interpersonal Problems - IIP) | — |
| At post-treatment, 6 and 12 month follow-ups: | — |
| 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 | — |
| meta-cognitions (Meta Cognitions Questionnaire) | — |
| worry (Penn State Worry Questionnaire, PSWQ) | — |
Countries
Germany
Outcome results
None listed