Effectiveness of a Dialogue-based Online Intervention Against Migraine

NCT04276142 | Completed

• 1 other identifier: ceprica trial
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Keywords

ceprica; online intervention; headache

Outcome Measures

Primary Outcomes (1)

• Number of days with migraine headache

  Change since baseline in migraine headache days per 28 days; assessed via diary

  3 months

Secondary Outcomes (9)

• Migraine-related disability

  3 months

• Use of acute migraine medication

  3 months

• Number of moderate/severe headache days

  3 months

• Migraine days responder rate

  3 months

• Headache-related pain intensity

  3 months

Other Outcomes (3)

• Sociodemographic variables

  Baseline Assessment

• Treatment Satisfaction

  T1 Assessment

• Healthy lifestyle

  3 months

Study Arms (2)

Migraine - ceprica

EXPERIMENTAL

online program: ceprica in addition to treatment as usual

Behavioral: ceprica (additional to treatment as usual)

Migraine - active control intervention

OTHER

active control intervention: psychoeducation in addition to treatment as usual

Behavioral: active control intervention (additional to treatment as usual)

Interventions

ceprica (additional to treatment as usual) BEHAVIORAL

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.

Migraine - ceprica

active control intervention (additional to treatment as usual) BEHAVIORAL

the active control intervention contains psychoeducational content regarding migraine

Migraine - active control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 at the time of screening
• fulfill diagnostic criteria of migraine (ICD-10: G43.0 or G43.1, confirmed either by upload of a medical document issued by a medical specialist or by a diagnostic phone/video call with a study physician who is experienced in headache diagnostics)
• age at onset of migraine \<50y
• Migraine is present for at least 12 months at the time of study entry
• migraine headache days per 28 days
• able and willing to give signed informed consent
• sufficient language skills in German

You may not qualify if:

• currently receiving preventive migraine medication within 60 days of T0, or planning to start another preventive treatment during the course of the study
• routinely taking, or planning to take, gepant-type acute migraine medication (e.g., rimegepant)
• Botulinum toxin A and B administered in the head or neck area within 4 months prior to T0
• patients with a history of failure to respond to 3 or more classes of migraine preventive treatments with good scientific evidence
• patients with regular intake of analgesics for other reasons than headache (e.g., chronic back pain, (rheumatoid) arthritis, cancer, injuries/accidents)
• patients with incomplete headache diaries at baseline (\>6 non-consecutive days within 28 days missing)
• patients with substance use disorder

Sponsors & Collaborators

• Gaia AG: lead

Study Sites (1)

GAIA

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gitta Jacob, PD PhD

  Gaia AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) psychoeducational active control intervention in addition to treatment-as-usual

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: June 5, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

DE (1)