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Effectiveness of a Dialogue-based Online Intervention Against Migraine

NCT04276142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2024-09-05

No results posted yet for this study

Summary

This trial was designed to evaluate the effectiveness of a dialogue-based online intervention (ceprica) that provides information regarding cognitive behavioural therapy (CBT) in patients with migraine.

The study aims to test the hypothesis that ceprica has a greater positive impact on migraine symptoms than an active control intervention providing psychoeducational content. Patients fulfilling ICHD-criteria for migraine will be randomized and allocated to either an intervention group, receiving ceprica in addition to treatment as usual, or a control group, which receives access to an active control intervention in addition to treatment as usual. The primary endpoint is the number of migraine days per month.

Conditions

Interventions

BEHAVIORAL

ceprica (additional to treatment as usual)

ceprica is a dialogue-based online psychological intervention for patients with migraine. This intervention includes elements that address pain management, pain reduction etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.

BEHAVIORAL

active control intervention (additional to treatment as usual)

the active control intervention contains psychoeducational content regarding migraine

Sponsors & Collaborators

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Gitta Jacob, PD PhD · Gaia AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2024-08-20
Completion
2024-08-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276142 on ClinicalTrials.gov