Panic DisorderNCT03885453
Construction of a Questionnaire on Panic Disorder and Agoraphobia
An observational study of Panic Disorder and Panic Disorder With Agoraphobia, run by Ulrike Willutzki at 1 site in Germany.
Trial summary
For the first time panic disorder and agoraphobia are included as separate disorders in the DSM-5. Thus, agoraphobia no longer represents a subcategory of panic disorder. To diagnose both of the disorders, questionnaires are the method of choice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Panic Disorder, Panic Disorder With Agoraphobia, Agoraphobia
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2019to 1 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with Panic Disorder / Agoraphobia / Depression
Who may be able to join
- Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Witten/Herdecke University
Witten, North Rhine-Westphalia, 58455
Ulrike Willutzki, Prof, +49 (0)2302 / 926-767, Ulrike.Willutzki@uni-wh.de
About this study
For the first time panic disorder and agoraphobia are included as separate disorders in the DSM-5. Thus, agoraphobia no longer represents a subcategory of panic disorder. To diagnose both of the disorders, questionnaires are the method of choice. However, there are no measuring instruments available free of charge in German-speaking countries. In order to improve this situation, the Witten Panic Disorder Questionnaire (WPF) and the Witten Agoraphobia Questionnaire (WAF) are constructed in accordance with the DSM-5 criteria. Both measuring instruments are included as a part of a ten instrument battery. WAF and WPF will be delivered to a patient sample of patients with panic disorder and/or agoraphobia as well as depressed patients (discriminant validity). Factor analyzes and item analyses will be conducted.
- Conditions
- Panic Disorder, Panic Disorder With Agoraphobia, Agoraphobia, Agoraphobia With Panic Attacks, Depression
- Medical subject headings
- Panic Disorder, Agoraphobia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Panic Disorder / Agoraphobia | Patients with Panic Disorder / Agoraphobia as major diagnosis | |
| Depression | Patients with Depression as major diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wittener Panik Fragebogen (WPF)
Self developed panic disorder questionnaire. Measures panic symptoms on one scale. Items are averaged. Range: 1-5. Higher values represent a worse outcome.
Measured: 5 min
WAF
Self developed agoraphobia questionnaire. Measures agoraphobia symptoms on two scales (Fear and Avoidance). Items are averaged to calculate the subscales. Range: 1-5 (Fear); 1-3 (Avoidance). Higher values represent a worse outcome.
Measured: 10 min
Secondary outcomes (8)
Agoraphobic Cognition Questionnaire (ACQ)
Chambless et al. (1985); Ehlers et al. (1993). The questionnaire measures anxious thoughts on two scales: Loss of Control and Physical Concerns. Items are averaged to calculate the subscales. Range: 1-5. A total score is calculated by averaging all items. Higher values represent a worse outcome.
Measured: 5 min
Body Sensations Questionnaire (BSQ)
Chambless et al. (1985); Ehlers et al. (1993). The questionnaire measures body sensations that may occur in a feared situation. Items are averaged to calculate a total score. Range: 1-5. Higher values represent a worse outcome.
Measured: 5 min
Mobility Inventory (MI)
Chambless et al. (1985); Ehlers et al. (1993). The questionnaire measures avoidance of agoraphobic situations on two scales (Avoidance Alone and Avoidance Accompanied). Items are averaged to calculate the scales. Range: 1-5. Higher values represent a worse outcome.
Measured: 10 min
Agoraphobic Self-Statements Questionnaire (ASQ)
Hout et al. (2001). Measures agoraphobic statements on two scales (positive self-statements and negative self-statements). Items are averaged. Range: 0-4. Higher values represent a better outcome on the positive scale and a worse outcome on the negative scale.
Measured: 5 min
Agoraphobic Cognitions Scale - extended version (ACS+)
Hoffart et al. (1992). Measures fearful cognitions on three scales (fear of bodily incapacitation, fear of losing control, and fear of acting embarrassingly). Items are averaged to calculate the scales. Range: 0-4. Higher values represent a worse outcome.
Measured: 5 min
Patient Health Questionnaire - D (PHQ-D) - Subscale Panic Syndrome
Spitzer, Kroenke \& Williams (1999); Löwe et al. (2002). The questionnaire measures symptoms on modular scales. The panic syndrome subscale is calculated by summing up all 11 items. The scale ranges from 0 to 1. The sum score ranges from 0 to 11. Higher values represent a worse outcome.
Measured: 5 min
Brief Symptom Inventory (BSI)
Derogatis \& Melisaratos (1983); Franke (2000). Measures psychopathological symptoms on nine scales (Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism). Items are averaged to calculate the subscale scores. Range: 0-4. The Global Severity Index (GSI) is calculated by averaging all items. Higher values represent a worse outcome.
Measured: 10 min
Beck Depression Inventory (BDI)
Beck et al. (1961). Measures depressive symptoms on one scale. Items summed up to calculate the toal score. The scale ranges from 0 to 3. The sum score ranges from 0 to 63. Higher values represent a worse outcome.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startMar 2019 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrike Willutzki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrike Willutzki, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885453
- Sponsor's protocol ID
- 08/2018
- Status last verified
- Mar 2019
- First submitted
- 5 Dec 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Questionnaire on Panic Disorder and Agoraphobia
- ClinicalTrials.gov ID
- NCT03885453
- Acronym / sponsor ID
- 08/2018
- Conditions
- Panic Disorder, Panic Disorder With Agoraphobia, Agoraphobia, Agoraphobia With Panic Attacks, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ulrike WillutzkiUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Mar 2019 (actual)
- 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.
For the first time panic disorder and agoraphobia are included as separate disorders in the DSM-5. Thus, agoraphobia no longer represents a subcategory of panic disorder. To diagnose both of the disorders, questionnaires are the method of choice. However, there are no measuring instruments available free of charge in German-speaking countries. In order to improve this situation, the Witten Panic Disorder Questionnaire (WPF) and the Witten Agoraphobia Questionnaire (WAF) are constructed in accordance with the DSM-5 criteria. Both measuring instruments are included as a part of a ten instrument battery. WAF and WPF will be delivered to a patient sample of patients with panic disorder and/or agoraphobia as well as depressed patients (discriminant validity). Factor analyzes and item analyses will be conducted.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panic Disorder / Agoraphobia | – | –Patients with Panic Disorder / Agoraphobia as major diagnosis |
| Depression | – | –Patients with Depression as major diagnosis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Panic Disorder / Agoraphobia / Depression
Key inclusion criteria (1 listed)
- Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wittener Panik Fragebogen (WPF)
Time frame: 5 min
Self developed panic disorder questionnaire. Measures panic symptoms on one scale. Items are averaged. Range: 1-5. Higher values represent a worse outcome.
WAF
Time frame: 10 min
Self developed agoraphobia questionnaire. Measures agoraphobia symptoms on two scales (Fear and Avoidance). Items are averaged to calculate the subscales. Range: 1-5 (Fear); 1-3 (Avoidance). Higher values represent a worse outcome.
8 secondary outcomes
Agoraphobic Cognition Questionnaire (ACQ)
Time frame: 5 min
Body Sensations Questionnaire (BSQ)
Time frame: 5 min
Mobility Inventory (MI)
Time frame: 10 min
Agoraphobic Self-Statements Questionnaire (ASQ)
Time frame: 5 min
Agoraphobic Cognitions Scale - extended version (ACS+)
Time frame: 5 min
Patient Health Questionnaire - D (PHQ-D) - Subscale Panic Syndrome
Time frame: 5 min
Brief Symptom Inventory (BSI)
Time frame: 10 min
Beck Depression Inventory (BDI)
Time frame: 10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder and Panic Disorder With Agoraphobia, run by Ulrike Willutzki 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wittener Panik Fragebogen (WPF) (time frame: 5 min). 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 21 Mar 2019.