Effectiveness of a Dialogue-based Online Intervention Against Migraine (EU-OPTMi)

Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: ceprica (additional to treatment as usual); Behavioral: active control intervention (additional to treatment as usual)

Detailed Description

Migraine is common in the German population and leads to a decreased quality of life as well as high economic consequences. Cognitive behavioural therapy has shown to be effective in the treatment of migraine. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective.

In this study, the treatment effects of a novel dialogue-based online intervention compared to a psychoeducational control intervention will be investigated. The interventional online program ceprica contains elements of cognitive behavioural therapy that address specific approaches in the management of pain, integrated in an individually tailored dialogue that is based on the responses given in the program. The intervention ceprica, as well as the psychoeducational control intervention, aer both delivered via the internet and protected by individually assigned passwords.

This randomised controlled trial will include 306 patients with migraine. Participants will be recruited via a website containing relevant information about the study. Participants will be randomly assigned in a 1:1 ratio to either a control group, in which they continue their usual treatment and receive access to a psychoeducational control intervention, or an intervention group who may also use treatment as usual and in addition receives the online intervention ceprica. Data are collected at baseline (T0) and three months after allocation (T1).

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22085
    • GAIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 4-14 migraine headache days per 28 days
• able and willing to give signed informed consent
• sufficient language skills in German

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Migraine - ceprica; online program: ceprica in addition to treatment as usual	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.
Other: Migraine - active control intervention; active control intervention: psychoeducation in addition to treatment as usual	Behavioral: active control intervention (additional to treatment as usual); the active control intervention contains psychoeducational content regarding migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days with migraine headache	Change since baseline in migraine headache days per 28 days; assessed via diary	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine-related disability	assessed via the Headache Impact Test (HIT-6); scale range from 36-78	3 months
Use of acute migraine medication	change from baseline in days with use of acute migraine medication per 28 days; assessed via diary	3 months
Number of moderate/severe headache days	Change since baseline in moderate/severe headache days per 28 days; assessed via diary	3 months
Migraine days responder rate	Proportion of participants achieving at least 50% reduction from baseline in migraine days	3 months
Headache-related pain intensity	assessed via a categorical, four-point verbal rating scale (no pain, mild pain, moderate pain, severe pain) on each day of each 28-day diary period	3 months
Functional impairment due to migraine	Assessed via the Functional Impairment Scale on each day of the 28-day diary period; scale range: 0-3	3 months
Depressive symptoms	measured via Patient Health Questionnaire (PHQ-9); scale range: 0 to 27	3 months
Anxiety symptoms	measured via Generalized Anxiety Disorder Assessment (GAD-7); scale range: 0 to 21	3 months
Migraine attacks	Change since baseline in migraine attacks per 28 days; assessed via diary	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy lifestyle	physical activity, sleep hygiene, healthy diet	3 months
Sociodemographic variables	age, gender, familial status, socioeconomic status, level of education, language ability	Baseline Assessment
Treatment Satisfaction	Measured by Net Promoter Score	T1 Assessment

Collaborators and Investigators

• Sponsor: Gaia AG
• Investigators: Principal Investigator: Gitta Jacob, PD PhD, GAIA AG

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: headache; online intervention; ceprica
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: ceprica trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No