Psychotherapy of Generalized Anxiety Disorder | NCT00118001

Studies
Psychotherapy of Generalized Anxiety Disorder

NCT00118001

Sponsor

German Research Foundation

Status

Completed

Last Update Posted

Apr 1, 2015Estimated

Enrollment

Phase

Phase 3

Conditions

Anxiety Disorders

Interventions

Worry exposure
Applied relaxation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Jun 30, 2005

First Submission Date that Met QC Criteria

Jul 8, 2005

First Posted Date

Jul 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jürgen Hoyer, PhD	Technische Universität Dresden	Principal Investigator
Eni S Becker, PhD	University of Nijmegen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technische Universität Dresden		Dresden		01187	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D000098647	Generalized Anxiety Disorder

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Worry exposure	Behavioral
Applied relaxation	Behavioral