RELIEF-Cluster: An Early-Stage Treatment Development Study for a Behavioral Intervention in Cluster Headache (Behavioral Intervention for Reducing Emotional Load and Improving Everyday Functioning in Cluster Headache)

RELIEF-Cluster: An Early-Stage Treatment Development Study for a Behavioral Intervention in Cluster Headache (Behavioral Intervention for Reducing Emotional Load and Improving Everyday Functioning in Cluster Headache) - RELIEF-Cluster Stage 1

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038585

Enrollment

Registered

2026-01-07

Start date

2026-01-10

Completion date

Unknown

Last updated

2026-06-22

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: Focus group interviews with patients after outpatient behavioral treatment (pain management) at the Headache Center Frankfurt

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) • Received a behavioral treatment (pain management) at the Headache Center Frankfurt • Informed consent has been obtained

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
A focus group interview (4–6 former patients as participants, duration approximately 3 hours) will be conducted to explore key aspects of a previously delivered outpatient group therapy program (behavioral pain management at a headache center), including: • experiences with the previous treatment, • approaches to managing the condition, • needs and expectations regarding a future treatment program.” The aim is to assess changes (both positive and negative) in patients as a result of a behavioral pain management group therapy, as well as their personal significance and attribution (e.g., whether or not they are related to the intervention), to assess the absence of desired changes or treatment elements, and to assess aspects of the intervention that were assessed as helpful, hindering, difficult, or lacking. The interviews will be conducted by trained interviewers who are bound to confidentiality. The interviews will be audio recorded, then anonymized and transcribed. The transcription will be AI-based using the “noScribe” software.	—

Measure

Time frame

A focus group interview (4–6 former patients as participants, duration approximately 3 hours) will be conducted to explore key aspects of a previously delivered outpatient group therapy program (behavioral pain management at a headache center), including: • experiences with the previous treatment, • approaches to managing the condition, • needs and expectations regarding a future treatment program.” The aim is to assess changes (both positive and negative) in patients as a result of a behavioral pain management group therapy, as well as their personal significance and attribution (e.g., whether or not they are related to the intervention), to assess the absence of desired changes or treatment elements, and to assess aspects of the intervention that were assessed as helpful, hindering, difficult, or lacking. The interviews will be conducted by trained interviewers who are bound to confidentiality. The interviews will be audio recorded, then anonymized and transcribed. The transcription will be AI-based using the “noScribe” software.

—

Secondary

Measure	Time frame
The following additional parameters will be collected by paper-pencil questionnaire: • sociodemographic data (including age, gender, educational status, family-/relationship status) • medical history data (diagnosis, duration of disorder)	—

Countries

Germany

Contacts

Public ContactTimo Klan

Psychologisches Institut der Johannes Gutenberg-Universität Mainz

klan@uni-mainz.de+49 6131 3939112

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026