NCT00118001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 1, 2015

Status Verified

June 1, 2005

First QC Date

June 30, 2005

Last Update Submit

March 31, 2015

Conditions

Anxiety Disorders

Keywords

PsychotherapyGeneralized Anxiety Disorderrandomized-controlled trialworry exposureapplied relaxation

Outcome Measures

Primary Outcomes (2)

  • 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 (9)

  • 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)

  • +4 more secondary outcomes

Interventions

Worry exposureBEHAVIORAL
Applied relaxationBEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Diagnosis of generalized anxiety disorder (according to impairment)
  • years of age
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden

Dresden, 01187, Germany

Location

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jürgen Hoyer, PhD

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

  • Eni S Becker, PhD

    University of Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

October 1, 2001

Study Completion

July 1, 2006

Last Updated

April 1, 2015

Record last verified: 2005-06

Locations

DE(1)