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Completed

NCT Number: NCT00118001

Psychotherapy of Generalized Anxiety Disorder

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.

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Technische Universität Dresden

Dresden, 01187, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Worry exposure

Behavioral

Applied Relaxation

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

German Research Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2006
First posted
Jul 11, 2005
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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