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Construction of a Questionnaire on Panic Disorder and Agoraphobia

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ClinicalTrials.gov Identifier: NCT03885453
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ulrike Willutzki, University of Witten/Herdecke

Study Description
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Brief 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 Thus, agoraphobia no longer represents a subcategory of panic disorder.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. 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.

Condition or disease
Panic Disorder Panic Disorder With Agoraphobia Agoraphobia Agoraphobia With Panic Attacks Depression

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Construction of a Questionnaire on Panic Disorder and Agoraphobia
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder

Groups and Cohorts
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Group/Cohort
Panic Disorder / Agoraphobia
Patients with Panic Disorder / Agoraphobia as major diagnosis
Depression
Patients with Depression as major diagnosis


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with Panic Disorder / Agoraphobia / Depression
Criteria

Inclusion Criteria:

Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885453


Locations
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Germany
Witten/Herdecke University Recruiting
Witten, North Rhine-Westphalia, Germany, 58455
Contact: Ulrike Willutzki, Prof    +49 (0)2302 / 926-767    Ulrike.Willutzki@uni-wh.de   
Sponsors and Collaborators
Ulrike Willutzki
More Information
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Responsible Party: Ulrike Willutzki, Clinical Professor, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT03885453    
Other Study ID Numbers: 08/2018
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Panic Disorder
Agoraphobia
 Pathologic Processes
Anxiety Disorders
Mental Disorders