German adaptation of the Cluster Headache Quality of Life Scale (CH-QoL)

• Conditions: G44.0; Cluster headache syndrome

• Registration Number: DRKS00028475
• Lead Sponsor: Psychologisches Institut der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Study Completion: 2023-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

(i) adults with
(ii) diagnosed cluster headache disorder (episodic or chronic cluster headache) according to the International Headache Classification (ICHD-3) of the International Headache Society (IHS) and
(iii) disease duration of at least 12 months

Exclusion Criteria

Participants with an excessively fast completion time (relative speed index (RSI) > 2, Leiner et al., 2019) and the wrong answer to an instructed response item (IRI, Gummer et al., 2021) will be used as post-hoc exclusion criteria.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study is to develop a German version of the self-report questionnaire CH-QoL”. This is intended to expand the armamentarium of German questionnaires for the assessment of psychosocial factors (here: quality of life) in cluster headache.

Secondary Outcome Measures

Name	Time	Method
Socio-demographic (e.g., sex, partnership status, educational level) and disease related data (duration of disease, symptoms, treatment parameters) are collected. The disease related data is used to verify the cluster headache diagnosis as well. To determine convergent validity, the following questionnaires will be applied: SF-36 Fragebogen zum Gesundheitszustand (SF-36, Bullinger et al., 1995), EuroQol Questionaire (EQ-5D, deutsche Version, EuroQol Group, 1990), Clusterkopfschmerz Skalen (CHS, Klan et al., 2020), Cluster Headache Impact Questionnaire (CHIQ, Kamm et al., 2022), Fragebogen zur Lebensqualität bei Migräne, deutsche Version des Migraine-Specific Quality-of-Life Questionaire (MSQ v2.1, Glaxo Wellcome Inc., 1998), and Cogniphobia Scale for Headache Disorders (CS-HD, Seng et al, 2017 or Klan et al, in preparation). To determine divergent validity, the NEO-Five-Factor-Inventory (NEO-FFI-30, German 30-item-shortversion, Körner et al., 2015) will be applied.