- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885453
Construction of a Questionnaire on Panic Disorder and Agoraphobia
March 20, 2019 updated by: Ulrike Willutzki
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Thus, agoraphobia no longer represents a subcategory of panic disorder.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 Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Rhine-Westphalia
-
Witten, North Rhine-Westphalia, Germany, 58455
- Recruiting
- Witten/Herdecke University
-
Contact:
- Ulrike Willutzki, Prof
- Phone Number: +49 (0)2302 / 926-767
- Email: Ulrike.Willutzki@uni-wh.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Panic Disorder / Agoraphobia / Depression
Description
Inclusion Criteria:
Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Panic Disorder / Agoraphobia
Patients with Panic Disorder / Agoraphobia as major diagnosis
|
Depression
Patients with Depression as major diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 min
|
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.
|
10 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agoraphobic Cognition Questionnaire (ACQ)
Time Frame: 5 min
|
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.
|
5 min
|
Body Sensations Questionnaire (BSQ)
Time Frame: 5 min
|
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.
|
5 min
|
Mobility Inventory (MI)
Time Frame: 10 min
|
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.
|
10 min
|
Agoraphobic Self-Statements Questionnaire (ASQ)
Time Frame: 5 min
|
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.
|
5 min
|
Agoraphobic Cognitions Scale - extended version (ACS+)
Time Frame: 5 min
|
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.
|
5 min
|
Patient Health Questionnaire - D (PHQ-D) - Subscale Panic Syndrome
Time Frame: 5 min
|
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.
|
5 min
|
Brief Symptom Inventory (BSI)
Time Frame: 10 min
|
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.
|
10 min
|
Beck Depression Inventory (BDI)
Time Frame: 10 min
|
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.
|
10 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
December 5, 2018
First Submitted That Met QC Criteria
March 20, 2019
First Posted (ACTUAL)
March 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 20, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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