Construction of a Questionnaire on Panic Disorder and Agoraphobia

Sponsor

Ulrike Willutzki (Other)

Overall Status

Recruiting

CT.gov ID

NCT03885453

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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 Thus, agoraphobia no longer represents a subcategory of panic disorder.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	Intervention/Treatment	Phase
Panic Disorder Panic Disorder With Agoraphobia Agoraphobia Agoraphobia With Panic Attacks Depression

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Construction of a Questionnaire on Panic Disorder and Agoraphobia

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Panic Disorder / Agoraphobia Patients with Panic Disorder / Agoraphobia as major diagnosis
Depression Patients with Depression as major diagnosis

Outcome Measures

Primary Outcome Measures

Wittener Panik Fragebogen (WPF) [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 [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

Agoraphobic Cognition Questionnaire (ACQ) [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.
Body Sensations Questionnaire (BSQ) [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.
Mobility Inventory (MI) [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.
Agoraphobic Self-Statements Questionnaire (ASQ) [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.
Agoraphobic Cognitions Scale - extended version (ACS+) [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.
Patient Health Questionnaire - D (PHQ-D) - Subscale Panic Syndrome [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.
Brief Symptom Inventory (BSI) [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.
Beck Depression Inventory (BDI) [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

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Witten/Herdecke University	Witten	North Rhine-Westphalia	Germany	58455

Sponsors and Collaborators

Ulrike Willutzki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulrike Willutzki, Clinical Professor, University of Witten/Herdecke

ClinicalTrials.gov Identifier:

NCT03885453

Other Study ID Numbers:

08/2018

First Posted:

Mar 21, 2019

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Panic Disorder

Agoraphobia

Study Results

No Results Posted as of Mar 21, 2019