Construction of a Questionnaire on Panic Disorder and Agoraphobia

Depression Clinical Trial

Official title:

Construction of a Questionnaire on Panic Disorder and Agoraphobia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885453
• Other study ID #: 08/2018
• Status: Recruiting
• Start date: March 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2019
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Thus, agoraphobia no longer represents a subcategory of panic disorder.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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview

Exclusion Criteria:

Related Conditions & MeSH terms

• Agoraphobia
• Agoraphobia With Panic Attacks
• Depression
• Disease
• Panic Disorder
• Panic Disorder With Agoraphobia

Locations

Country	Name	City	State
Germany	Witten/Herdecke University	Witten	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Ulrike Willutzki

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 min
Primary	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.	10 min
Secondary	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.	5 min
Secondary	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.	5 min
Secondary	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.	10 min
Secondary	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.	5 min
Secondary	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.	5 min
Secondary	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.	5 min
Secondary	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.	10 min
Secondary	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.	10 min