Treatment-related changes in disability, distress, and quality of life in cluster headache: the CHANGES Study (Cluster Headache Assessment of Noticeable Gains in Experienced Symptoms)

Treatment-related changes in disability, distress, and quality of life in cluster headache: the CHANGES Study (Cluster Headache Assessment of Noticeable Gains in Experienced Symptoms) - CHANGES

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038069

Enrollment

Registered

2026-02-06

Start date

2026-02-11

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G44.0

Interventions

Group 1: Routine outpatient treatment at the Frankfurt Headache Center

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Confirmed diagnosis of episodic or chronic cluster headache according to ICHD-3 criteria of the International Headache Classification (IHS) • The participant is starting a new medical treatment or changing an existing medical treatment (e.g., change in prophylactic medication) • Informed consent has been obtained

Exclusion criteria

Exclusion criteria: • Lack of consent or lack of capacity to consent • Insufficient knowledge of German

Design outcomes

Primary

Measure	Time frame
Sensitivity to change of the disorder-specific questionnaires: CHS, CH-QoL, and CHIQ The questionnaires are used for: - a pre-measurement (T1) at the start of treatment, i.e., upon presentation to the Frankfurt Headache Center - a post-measurement (T2) 6 weeks after the start of treatment	—

Secondary

Measure	Time frame
only T1: • sociodemographic data (gender, relationship status, educational level, employment status, nicotine consumption) • medical history data (duration of disorder, symptoms, treatment history) at T1& T2: • generic questionnaires on psychological distress (DASS-21; Nilges et al., 2015), headache-related impairment (IBK; Bauer et al., 1999), health-related quality of life (EQ-5D-5L; Herdman et al., 2011) only T2: • information on treatment received between measurement points	—

Measure

Time frame

only T1: • sociodemographic data (gender, relationship status, educational level, employment status, nicotine consumption) • medical history data (duration of disorder, symptoms, treatment history) at T1& T2: • generic questionnaires on psychological distress (DASS-21; Nilges et al., 2015), headache-related impairment (IBK; Bauer et al., 1999), health-related quality of life (EQ-5D-5L; Herdman et al., 2011) only T2: • information on treatment received between measurement points

—

Countries

Germany

Contacts

Public ContactCarla Johanna Havenstein

Psychologisches Institut der Johannes Gutenberg-Universität Mainz

clusterkopfschmerz-befragung@uni-mainz.de+4961313932500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026