Anxiety DisordersPhase 3NCT00118001
Psychotherapy of Generalized Anxiety Disorder
A Phase 3 study testing Worry exposure and Applied relaxation in people with Anxiety Disorders, run by German Research Foundation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Worry exposure and Applied relaxation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2001to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Diagnosis of generalized anxiety disorder (according to impairment)
- 18-70 years of age
- Informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Worry Exposure Versus Applied Relaxation in the Treatment 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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Worry exposure, Applied relaxation
- Keywords
- Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worry exposureBehavioural
Applied relaxationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startOct 2001
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- German Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Jürgen Hoyer, PhD, Principal investigator, Technische Universität DresdenEni S Becker, PhD, Principal investigator, University of Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118001
- Sponsor's protocol ID
- HO 1900/3-1, HO 1900/3-2
- Status last verified
- Jun 2005
- First submitted
- 30 Jun 2005
- Last updated
- 1 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worry Exposure Versus Applied Relaxation in the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00118001
- Acronym / sponsor ID
- HO 1900/3-1, HO 1900/3-2
- Conditions
- Anxiety Disorders
- Keywords
- Psychotherapy, Generalized Anxiety Disorder, randomized-controlled trial, worry exposure, applied relaxation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- German Research FoundationUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Jul 2006
- First posted
- 11 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary Diagnosis of generalized anxiety disorder (according to impairment)
- 18-70 years of age
- Informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Worry exposure | Behavioural | – |
| Applied relaxation | Behavioural | – |
Primary outcome
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)
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Hoyer, PhD principal investigator
Technische Universität Dresden
Eni S Becker, PhD principal investigator
University of Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Worry exposure and Applied relaxation in people with Anxiety Disorders, run by German Research Foundation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At post-treatment: anxiety (Hamilton Anxiety Rating Scale, HARS), depression (Hamilton Depression Scale, HAM-D), trait-anxiety (State-Trait-Anxiety Inventory, STAI-T). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.