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Psychotherapy of Generalized Anxiety Disorder

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Worry exposure
Applied relaxation
Sponsored by
German Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Technische Universität Dresden

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 30, 2005
Last Updated
March 31, 2015
Sponsor
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00118001
Brief Title
Psychotherapy of Generalized Anxiety Disorder
Official Title
Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
German Research Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Hoyer, PhD
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eni S Becker, PhD
Organizational Affiliation
University of Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität Dresden
City
Dresden
ZIP/Postal Code
01187
Country
Germany

12. IPD Sharing Statement

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Psychotherapy of Generalized Anxiety Disorder

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